V1 HCS-Qualifications-Prospectus- ANDREA DI SQA Return DR171019[1] · 2019-10-29 · Australia SQA...

Healthcare Skills International

QUALIFICATION PROSPECTUS

The integrity of industry standards is the future of patient safety.

Healthcare Skills International

QUALIFICATION PROSPECTUS

Contents

Who we are

How we work with EduQual

Sales and Marketing Professional Framework

Learning & Development Professional Framework

Medical Device Regulations & Quality Management Systems

Framework Course Syllabus

Reasons to believe

Our Partners & Training Venues

Tel: +44(0) 141 946 6482 E- mai l : jane @ hea l t hcar esk i l l s .com

www. hea l t hca r esk i l l s . com

Copyright© Diane Irvine 2000 (Updated 2019) 2

The qualifications we offer are from a government awarding body:

• Post-Graduate Diplomas • Certificates • Professional Awards

WHO WE ARE

We are an approved education centre delivering a range of externally validated, competence-based qualifications to the medical profession and healthcare industry that are internationally recognised.

Healthcare Skills International is a dedicated group of healthcare professionals based at West of Scotland Science Park who aim to guarantee the future of patient safety and the integrity of medical standards through credible qualifications that meet all relevant legal, ethical and professional standards.

Our courses for clinicians allow them to add to their skill sets and garner new qualifications which will help them to develop their careers and improve their professional standing.

The programmes we offer to individuals who work in the medical device sector and who are required to be present in clinically acute areas – to assist surgical teams – allow them to formally demonstrate a level of competence that assures patient safety and ensures medical standards are not compromised, professionally or legally.

All our qualifications are compliance-driven. Furthermore, they are fully accredited and validated and they fulfill legal and regulatory requirements as well as meeting the criteria set by professional bodies and other stakeholders.

Training programmes usually follow a blended learning format, consisting of a mixture of online, classroom and practical environment settings. Only one of our courses – which is for company representatives in hospitals working where patients

are not present – is available to be completed exclusively online, although it includes an infection control exercise that follows a practical format.

All of our programmes are delivered by respected medical practitioners who have defining knowledge and experience in their field. In addition to their designated professional qualifications, they all hold additional certification in clinical education and have responsibilities in their daily working lives that guarantee that the information they impart is current, credible and relevant.


Are you Trained or Qualified?

Those who have completed our courses include: • Practicing medics (surgeons, physicians, all medical practitioners) • Pharmacists • Nurses • Medical Device company representatives • Pharmaceutical company representatives • Regulatory personnel in companies that manufacture, sell or place

medical devices on the market

The outcomes for those who successfully complete them are: • An understanding of what constitutes best practice and key skills in a

clinical environment • A firm grasp of legal obligations in hospital and clinical settings • An ability to assimilate the expectations of members of the clinical

team • The acquisition of skills that will help to improve training approaches

and skills to maximise clinical output • An understanding of detailed regulatory requirements and implications

of medical device legislation • The potential to develop their skill sets to a level of medical device

formal/corporate sign-off • An understanding of obligations relating to the sale of and correct

patient use of medical devices and required reporting/record-taking

“Healthcare Skills International ensure that the highest ethical, legal and teaching standards are maintained through the delivery of our professional qualification programmes”

All those who take part in our courses are able to legitimately demonstrate a level of competence that meets all relevant professional requirements reflecting the national qualifications framework.

Healthcare Skills provide the following qualifications framework that is defined by national standards and meets all relevant requirements and registration systems: • Post-graduate Diploma in Computer Assisted Surgery • Post-graduate Diploma in Clinical Education • Orthopaedic Healthcare Industry Professional Diploma • Media engagement for healthcare professionals – Certificate and

Diploma • Suite of medical device regulatory and medical device commercial

qualifications – Certificate and Diploma • Advanced Professional Award in Hospital Procurement • Hospital Access/Theatre (OR) Skills – Professional Award • Pharmaceutical Ethics – Certificate and Diploma

) Copyright© Diane Irvine 2000 (Updated 2019) 4

Clinical Lead for Healthcare Skills International


Healthcare Skills International is an approved audited education centre, delivering a range of professional, competence-based qualifications awarded by EduQual.

Why do Healthcare Skills work with EduQual? 1. Professional Healthcare Skills qualifications developed with

employers. EduQual work with the relevant sector skills bodies and industry professionals to ensure that the qualifications they offer meet the needs of employers and provide the latest industry thinking.

2. Guaranteed and reliable quality The validity of EduQual qualifications is underpinned by commitment to the highest standards of quality. Qualifications are developed in line with the standards specified by the Regulatory Principles of SQA-Accreditation and Ofqual's Regulated and Qualifications Framework (RQF). SQA Accreditation and Ofqual are UK national regulators.

3. Delivering ‘fit for purpose’ ready certified professionals. Completing an EduQual professional qualification with Healthcare Skills means you are ready to enter the workplace. Each candidate is certified by EduQual as having demonstrated that they have the skills they need to operate effectively in their chosen industry.

With EduQual qualifications delivered by Healthcare Skills, corporations’ representatives can provide externally validated evidence of competence to demonstrate, teach, support and promote their products.

EduQual is a UK awarding organisation which develops and accredits qualifications designed to meet the needs of learners and industry sectors and to provide individuals with opportunities for personal and professional development. EduQual qualifications are develop in accordance with the standards specified by: • The regulatory principles of SQA Accreditation and the Scottish Qualifications

and Credit Framework (SCQF) • Ofqual’s general condisitons of recognition and the Regulated Qualifications

Framework (RQF)

“Working with EduQual has been a great success. Through EduQual, Healthcare Skills are able to deliver professional qualifications based on professional standards. There are many training courses available for business professionals; the advantage of EduQual courses is that learners achieve professional qualifications."

Diane Irvine, CEO, Healthcare Skills

HOW DO HEALTHCARE SKILLS INTERNATIONAL WORK WITH EduQual?

Qualification Level – SCQF/RQF

Award 10-120 Hours

Certificate 130 - 360 Hours

Diploma 370 - 900 Hours

Extended Diploma >900 Hours

Level Descriptors

11/7 Postgraduate Award

Postgraduate Certificate

Postgraduate Diploma

Extended Postgraduate Diploma

Achievement at this level reflects the ability to reformulate and use relevant understanding, methodologies and approaches to address problematic situations that involve many interacting factors. It includes taking responsibility for planning and developing courses of action that initiate or underpin substantial change or development, as well as exercising broad autonomy and judgment. It also reflects an understanding of relevant theoretical and methodological perspectives, and how they affect their area of study or work.

10/6 Graduate Award

Graduate Certificate

Graduate Diploma

Extended Graduate Diploma

Achievement at this level reflects the ability to refine and use relevant understanding, methods and skills to address complex problems that have limited definition. It includes taking responsibility for planning and developing courses of action that are able to underpin substantial change or development as well as exercising broad autonomy and judgment. It also reflects an understanding of different perspectives, approaches or schools of thought and the theories that underpin them.

8-9/5 Advanced Professional Award

Advanced Professional Certificate

Advanced Professional Diploma

Extended Advanced Professional Diploma

Achievement at this level reflects the ability to identify and use relevant understanding, methods and skills to address broadly-defined, complex problems. It includes taking responsibility for planning and developing courses of action as well as exercising autonomy and judgment within broad parameters. It also reflects understanding of different perspectives, approaches or schools of thought and the reasoning behind them.

7-8/4 Professional Award

Professional Certificate

Professional Diploma

Extended Professional Diploma

Achievement at this level reflects the ability to identify and use relevant understanding, methods and skills to address problems that are well defined but complex and non-routine. It includes taking responsibility for overall courses of action as well as exercising autonomy and judgment within fairly broad parameters. It also reflects understanding of different perspectives or approaches within an area of study or work.

6-7/3 Advanced Award

Advanced Cer- tificate

Advanced Diploma

Extended Advanced Diploma

Achievement at this level reflects that ability to identify and use relevant understanding, methods and skills to complete tasks and address problems that, while well defined, have a measure of complexity. It includes taking responsibility for initiating and completing tasks and procedures as well as exercising autonomy and judgment within limited parameters. It also reflects awareness of different perspectives or approaches within an area of study or work.

5/2 Intermediate Award

Intermediate Certificate

Intermediate Diploma

Extended Intermediate Diploma

Achievement at this level reflects the ability to select and use relevant knowledge ideas, skills and procedures to complete well-defined tasks and address straightforward problems. It includes taking responsibility for completing tasks and procedures and exercising autonomy and judgment subject to overall direction or guidance.

4-5/1 Foundation Award

Foundation Certificate

Foundation Diploma

Extended Foundation Diploma

Achievement at this level reflects the ability to use relevant knowledge, skills and procedures to complete routine tasks. It includes responsibility for completing tasks and procedures subject to direction or guidance.

1-3/Entry Entry Award Entry Certificate

Entry Diploma

Extended Entry Diploma

Achievement at this level reflects progress towards making use of skills, knowledge and understanding (i) that relate to the immediate environment, or (ii) to carry out simple familiar tasks and activities with guidance, or (iii) to carry out structured tasks and activities with guidance.



HCS Table of Equivalences

Ofqual

Europe

Australia SQA Accreditation

EduQual

Level

RQF

Equivalencies

EQF

Equivalencies

AQF

Equivalencies

SCQF

Equivalencies

1

1 Entry Level (14 yrs old)

2

2

4/5

2

2 GCSE

3

3

5

3 3

A Level

4

4

6/7

4

4 Professional

5

5

7/8

5

5 Undergraduate (foundation)

5

6

8/9

6

6 Yr 2/3 graduate (degree course)

6

8

10

7

7 Post Graduate

7

9

11


SALES AND MARKETING Healthcare Skills International Professional Development Journey

HOSPITAL ACCESS

RESILIENT SELLING

THEATRE ACCESS

(SCQF Level 6) (EduQual Level 5) (SCQF Level 8)

The Professional Medical Device Qualifications Framework The Professional Medical Device Qualifications framework is timely against the current background of clinical governance. Healthcare Skills believe that with these externally validated competence based qualifications, individuals with this level of knowledge and skill will be competent, credible and inspire confidence.

The MD Qualifications Framework underpins the best levels of clinical support and compliance in the medical device industry. All of the qualifications develop the knowledge and skills necessary to achieve and maintain commercial success. The framework supports the roles of sales and marketing, Training and leadership, and the medical device regulatory professionals.

Foundation Phase


PROCUREMENT

(EduQual Level 5)

LEADERSHIP AND HUMAN FACTORS

(EduQual Level 7)

“The best support any organisation can provide for employees is proper and appropriate training. For this training to be externally validated and quality assured is the gold standard of professional management and staff development.”

Specialty Phase

Clinical Director General Surgery – Greater Glasgow & Clyde


SALES AND MARKETING Healthcare Skills International Professional Development Journey

Target

This development journey is intended to for i the continuing professional development of t individuals for whom sales and marketing rol expected to form the primary function of thei within the healthcare industry.

A mix of levels 3, 5 and 7 (RQF) and 6, 8 (SCQF). These Professional Qualifications are structured in such a way as to provide a learning journey of increasing knowledge and practical application specific to their role.

Whilst learners can progress through the journey at their own pace, it is envisaged that the framework could provide a competence based training programme over a minimum five year period with further ongoing re-accreditation.

m the basis of hose es are ir job roles

Course Overviews Award in Access to Hospitals (SCQF Level 6)

see equivalence table page 7

This award develops the knowledge and skills which hospital management expect of anyone whose role requires them to access hospital areas but whom are not present during patient interventions. This qualification is SCQF credit rated by SQA Awarding and quality assured by EduQual.

“Healthcare Skills are about more than training. Its courses are prepared and delivered by practitioners who have faced the same issues and pressures as their delegates. Healthcare Skills has a unique combination of understanding, practicality and regulation that only an experienced team like this can deliver.”

Partner, Head of Corporate, Gilson Gray LLP

Outcomes

• Apply the principles of safe practice within critical care

areas • Identify and manage a range of risks and potential

hazards associated with the anesthetic and critical care environment

• Identify and comply with the health and safety requirements within the hospital environment

• Comply with and demonstrate the principle elements of standard precautions and infection control within a critical care setting


Resilient Selling, EduQual Level 5

This unit develops the knowledge and skills required to have an understanding of Human Factors and Resilience, and their importance in the commercial environment. The qualification establishes the professional competencies necessary to identify the nature of Human Factors and Resilience and develop strategies for individuals, alone and in a team, to use awareness of these factors to maintain commercial success.

Outcomes • examine the basic understanding of Human Factors and their

importance in maintaining clinical and commercial success • establish the professional competencies necessary to

identify the nature of Human Factors and develop strategies for working both alone and in a team

• use awareness of these factors to avoid common errors in the commercial process

• enable the delegate to develop decision making strategies taking into account Human Factors and Resilience

Award in Access to Operating Theatres (SCQF Level 8) - see equivalence table page 7

This award develops the knowledge and skills which hospital management expect of medical device industry personnel entering, assisting and providing verbal/technical input within clinical areas during patient interventions.This qualification is SCQF credit rated by SQA Awarding and is also a nationally regulated qualification. It is quality assured by EduQual and subject to audit by the national regulator, SQA-Accreditation.

Outcomes • Develop, implement and evaluate a personal code of conduct

to be utilised when working in the operating theatre environment • Utilise a risk assessment methodology to identify and manage

the range of risks and potential hazards associated within the operating department

• Identify the range of health and safety requirements of a named hospital, in which you have worked and evaluate your ability in meeting the identified requirements

• Evaluate personal ability to comply with the principles of standard precautions and infection control within the operating department

• Plan, implement and evaluate a session in which you have demonstrated a piece of equipment for which you have sales and backup responsibility

Procurement, EduQual Level 5

This course develops the knowledge and skills relevant to the management of sales and commercial relationships within the healthcare environment. The qualification establishes the set of professional competencies necessary to increase the chances of successful commercial outcomes by understanding more about the manner in which hospitals operate their procurement cycle.

Outcomes • Gain the knowledge of the unique commercial environment

of the NHS • Understand the Procurement function which operates within

the NHS and the methods currently applied during the procurement cycle

• Effectively represent your organisation by understanding the legal and regulatory environment in which they must operate

• Demonstrate the ability to sell in the way hospitals want to purchase

Leadership And Human Factors, EduQual Level 7 This unit develops the knowledge and skills required to teach a basic understanding of Human Factors and their importance in Leadership within the Healthcare industry. The qualification establishes the professional competencies necessary to identify the nature of Human Factors and develop strategies for individual workers, alone and in a team, to use awareness of these factors to more effectively lead towards the goal of improved patient outcomes.

Outcomes • Understand what Human Factors are and their role in creating high

performing teams • Understand the role of Human Factors within critical environments,

such as Healthcare and the impact they have in determining patient outcomes

• Understand how to create a culture which eliminates blame and encourages openness and support

• Understand the importance of situational awareness, prioritisation, decision making, and assertiveness to create high performing teams and positive patient outcomes


Healthcare Skills International Professional Development Journey

HOSPITAL ACCESS

(SCQF Level 6)

RESILIENT SELLING

(EduQual Level 5)

THEATRE ACCESS

(SCQF Level 8)

The Professional Medical Device Qualifications Framework

The Professional Medical Device Qualifications framework is timely against the current background of clinical governance. Healthcare Skills believe that with these externally validated competence based qualifications, individuals with this level of knowledge and skill will be competent, credible and inspire confidence.


Foundation Phase


PROCUREMENT CLINICAL EDUCATION

(EduQual Level 5) (EduQual Level 7)

“The F&P senior management team were the first to attend and gain the theatre access qualification that had been developed in conjunction with our professional body barema. Perhaps the most surprising result of this course was that a group of health care professionals with many years experience between us still had so much to learn… and learn we certainly did!

Without hesitation we decided to embark on a program of enrolling every member of staff whose job requires them to access theatres and critical care areas of the hospital.We have not completed this process yet but are completely commit to that end.

I would be proud to be part of an industry whose standards were set along the lines of those established by Healthcare Skills.”

Specialty Phase

General Manager, Fisher & Paykel Healthcare UK & Ireland


LEARNING AND DEVELOPMENT PROFESSIONAL FRAMEWORK

Healthcare Skills International Professional Development Journey

Target

This development journey is intended to form the basis of the continuing professional development of those individuals for whom Professional Education or Learning and Development roles are expected to form the primary function of their job roles within the healthcare industry.

A mix of levels 3, 5 and 7 (RQF) and 6, 8 (SCQF). These Professional Qualifications are structured in such as way as to provide a learning journey of increasing knowledge and practical application specific to their role. Whilst learners can progress through the journey at their own pace, it is envisaged that the framework could provide a competence based training programme over a minimum five year period with further ongoing re-accreditation.

Course Overviews Award in Access to Hospitals (SCQF Level 6)

see equivalence table page 7

This award develops the knowledge and skills which hospital management expect of anyone whose role requires them to access hospital areas. This qualification is SCQF credit rated by SQA Awarding and quality assured by EduQual.

Outcomes

• Apply the principles of safe practice within critical care areas

• Identify and manage a range of risks and potential hazards associated with the anesthetic and critical care environment

• Identify and comply with the health and safety requirements within the hospital environment Comply with and demonstrate the principle elements of standard precautions and infection control within a critical care setting

“Healthcare Skills have delivered a training program that challenges and

develops individuals in our organisation to be equipped as well as qualified for working in the hospital environment. This is a great course that helps to also learn from other organisations experiences”

Global Training Manager, Cochlear EMEA


Resilient Selling, EduQual Level 5

This unit develops the knowledge and skills required to have an understanding of Human Factors and Resilience, and their importance in the commercial environment. The qualification establishes the professional competencies necessary to identify the nature of Human Factors and Resilience and develop strategies for individuals, alone and in a team, to use awareness

of these factors to maintain commercial success.

Outcomes • Examine the basic understanding of Human Factors

and their importance in maintaining clinical and commercial success

• Establish the professional competencies necessary to

identify the nature of Human Factors and develop strategies for working both alone and in a team

• Use awareness of these factors to avoid common errors in the commercial process

• Enable the delegate to develop decision making strategies taking into account Human Factors and Resilience


This award develops the knowledge and skills which hospital management expect of medical device industry personnel entering, assisting and providing verbal/technical input within clinical areas. This qualification is SCQF credit rated by SQA Awarding and is also a nationally regulated qualification. It is quality assured by EduQual and subject to audit by the national regulator, SQA-Accreditation.

Outcomes • Develop, implement and evaluate a personal code of conduct

to be utilised when working in the operating theatre environment • Utilise a risk assessment methodology to identify and manage

the range of risks and potential hazards associated within the operating department




Procurement, EduQual Level 5

This course develops the knowledge and skills relevant to the management of sales and commercial relationships within the healthcare environment. The qualification establishes the set of professional competencies necessary to increase the chances of successful commercial outcomes by understanding more about the manner in which hospitals operate their procurement cycle.

Outcomes • Gain the knowledge of the unique commercial environment

of the NHS • Understand the Procurement function which operates within

the NHS and the methods currently applied during the procurement cycle

• Effectively represent your organisation by understanding the legal and regulatory environment in which they must operate

• Demonstrate the ability to sell in the way hospitals want to purchase

Clinical Education, EduQual Level 7

This unit develops the knowledge and skills relevant to teaching and learning processes. The qualification establish-es the set of professional competencies necessary to deliver structured, measured and effective teaching strategies. The programme identifies and assesses lecturing skills and the specific requirements for teaching clinical skills.

Outcomes • Understand principles, theories and domains to

enable learning • Understand how to apply Teaching and learning Strategies

• Understand Behavior types

• Understand Group learning

• Understand how effective communication enables learning

• Understand how to evaluate and improve own practice

• Plan the delivery of a clinical lecture and the clinical skill teaching

• Deliver the clinical lecture, and the clinical skill teaching

• Evaluate teaching practice from the lecture and clinical skill teaching


FRAMEWORK Healthcare Skills International Professional Development Journey

HOSPITAL ACCESS

THEATRE ACCESS

REGULATORY 1

(SCQF Level 6) (SCQF Level 8) (EduQual Level 5)

The Professional Medical Device Qualifications Framework

The Professional Medical Device Qualifications framework is timely against the current background of clinical governance. Healthcare Skills believe that with these externally validated competence based qualifications, individuals with this level of knowledge and skill will be competent, credible and inspire confidence.


Foundation Phase


REGULATORY 2 REGULATORY 3

(EduQual Level 5) (EduQual Level 7)

“For 20 years of medical device development experience I have been on many training courses that provide the qualification. This course is tailored from practical experiences to deliver insight into the regulations, development and delivery of products to market that has helped our team to hit the ground running and on-going support given on practical issues supports our business to deliver.”

Specialty Phase

Buisness Manager, Invibio


MEDICAL DEVICE REGULATIONS AND QUALITY MANAGEMENT SYSTEMS FRAMEWORK R&D, OR Technical Professionals Course Overviews

Target

This development journey is intended to form the basis of the continuing professional development of those individuals for whom Research and Development, Specialist Technical or Engineering roles are expected to form the primary function of their job roles within the healthcare industry.

A mix of levels 3, 5 and 7 (RQF) and 6, 8 (SCQF).These Professional Qualifications are structured in such as way as to provide a learning journey of increasing knowledge and practical application specific to their role.

Whilst learners can progress through the journey at their own pace, it is envisaged that the framework could provide a competence based training programme over a minimum five year period with further ongoing re-accreditation.

Course Overviews

Hospital Access, (SCQF Level 6) (see equivalence table page 7)

This award develops the knowledge and skills which hospital management expect of anyone whose role requires them to access hospital areas.

Outcomes • Apply the principles of safe practice within critical

care areas

• Identify and manage a range of risks and potential

hazards associated with the anesthetic and critical care environment

• Identify and comply with the health and safety requirements within the hospital environment

• Comply with and demonstrate the principle elements of standard precautions and infection control within a critical care setting


This qualification is SCQF credit rated by SQA Awarding and is also a nationally regulated qualification. It is quality assured by EduQual and subject to audit by the national regulator, SQA-Accreditation.

The award develops the knowledge and skills which hospital management expect of medical device industry personnel entering, assisting and providing verbal/technical input within clinical areas.

Outcomes

• Develop, implement and evaluate a personal code of conduct to be

utilised when working in the operating theatre environment

• Utilise a risk assessment methodology to identify and manage the range of risks and potential hazards associated within the operating department


“Thank you for making a complex subject like medical device regulations easier to access and understand”




Regulatory 1, EduQual Level 4

This unit will create Regulatory Medical Device professionals equipped with the basic technical knowledge, implementation skills and professional attitudes to deliver the highest standards of Healthcare Compliance in the Medical Devices sector of Life Sciences.

Outcomes • Increase learners’ academic knowledge and critical awareness

of the issues that comprise the Medical Device Regulations • Develop an understanding of how regulatory requirements

affect business practice • Allow applications to protect and sustain the company

activities in their area of responsibility • Determine appropriate compliance pathways, technical • Requirements and data • Enhance understanding of Quality Management Systems in

relation to the Medical Device Directive


This unit will create Regulatory Medical Device professionals equipped with the intermediate technical knowledge, implementation skills and professional attitudes to deliver the highest standards of Healthcare Compliance in the Medical Devices sector of Life Sciences. This unit builds on those outcomes achieved within the Level 4 Award.

Outcomes

• Define ‘Quality Systems’ and their role in ensuring quality within their organisation

• Define the key elements of the New Product Development (NPD) cycle

• Describe the sections of ISO 13485:2003 (Quality Management Systems for Medical Devices), and their intended purpose

• Identify where the sections of ISO 13485:2003 interact with the NPD cycle time line

• Define the fundamentals of Risk Management for a Medical Device to ISO 14971:2007 and explain how the related activities fit into the NPD cycle

• Outline the key elements of the EU Medical Device Directives, FDA and other regional regulations and technical standards


This unit will create Regulatory Medical Device professionals equipped with the advanced technical knowledge, implementation skills and professional attitudes to deliver the highest standards of Healthcare Compliance in the Medical Devices sector of Life Sciences.

Outcomes

• Understand the workings of the EC Institutions and be able

to relate this to the EC Medical Device Directives

• Understand the AIMD and the MDD • Determine the most appropriate compliance pathway,

determine the technical requirements and data needed, and develop a registration programme for all classes of medical device for each of the Directives

• Understand the IVDD and determine the most appropriate compliance pathway, determine the technical requirements and data needed, and develop a registration programme for in-vitro diagnostic medical device

• Understand the old and the new International quality system standards, and the supplementary standards for medical devices and their application to the manufacture of medical devices

• Understand auditing practice by complementing and supplementing the knowledge gained from the Quality System Standards Module

• Understand the International and European Standards Organisations, their procedures, and the way in which standards are developed and applied

• Understand key technical standards for medical devices and their significance for product design, product safety and regulatory compliance

• Understand microbiology as related to the manufacture of medical devices, the major methods of sterilization and their selection for types of medical devices and the materials of construction, and the principles of validation and their practical application

• Develop and manage a clinical investigation programme that would achieve regulatory approval in the key markets

• Understand the relevant regulations and requirements, the ability to determine the appropriate regulatory pathway, and the ability to develop and manage an effective process for obtaining market clearance

• Understand the relevant requirements, the ability to determine the appropriate regulatory pathway, and the ability to develop and manage an effective process for obtaining regulatory approval

• Understand the significance of the legal regulations in Europe to the manufacture of medical devices and will be able to relate in broad terms the principles to other markets

• Be able to prepare a regulatory submission and obtain regulatory approval

• Develop a broad understanding of the technical, safety, and ethical features inherent in the nature of these new technological biomedical devices, and an awareness of the emerging legislation

HEALTHCARE SKILLS INTERNATIONAL QUALIFICATION SYLLABUS



Award in Access to Hospitals (SCQF Level 6)

Award in Access to Operating Theatres (SCQF Level 8)

Postgraduate Diploma in Clinical Education

Professional Diploma Orthopeadic Healthcare Industry

Professional Certificate in Principles of Resilient Selling

Certificate in Principles Of Clinical Procurement

Professional Certificate in Fundamentals of Pharmaceutical Ethics &

The Code of Practice

Professional Medical Device Regulations Award

Professional Medical Device Regulations Professional Certificate

Professional Medical Device Regulations Graduate Diploma


Description This qualification is SCQF credit rated by SQA Awarding and quality assured by EduQual This award develops the knowledge and skills which hospital management expect of anyone whose role requires them to access hospital areas.

Assessment Criteria As a qualification there are three key elements to be met:

• Technical Knowledge• Clinical Skill• Reflective Practice

This unit will be assessed through three different activities:

• Candidates will complete a comprehensive written assessment which will includethe principles of Safe Practice within the relevant clinical areas

• Candidates will complete a multiple-choice questionnaire covering all aspects ofthe taught Hospital/Theatre Skills unit and its pre-course reading

• Candidates will be expected to demonstrate personal competencies in an actualhospital clinical area under simulated conditions

Delivery The programme will be delivered online and assessments are a combination of online assessments and practical assessment form to be signed off by hospital line manager.

Professional Hospital Access Qualification (Award in Access to Hospitals SCQF Level 6) (see equivalence table page 7)


Professional Theatre Access Qualification (Award in Access to Operating Theatres SCQF Level 8) (see equivalence table page 7)

Description This qualification is SCQF credit rated by SQA Awarding and is also a nationally regulated qualification. It is quality assured by EduQual and subject to audit by the national regulator, SQA Accreditation.

This award develops the knowledge and skills which hospital management expect of medical device industry personnel entering, assisting and providing verbal/technical input within clinical areas.

Assessment Criteria As a qualification there are three key elements to be met:

• Technical Knowledge• Clinical Skill• Reflective Practice


• Candidates will complete a comprehensive written assessment which will includethe principles of Safe Practice within the relevant clinical areas

• Candidates will complete a multiple-choice questionnaire covering all aspects ofthe taught Hospital/Theatre Skills unit and its pre-course reading

• Candidates will be expected to demonstrate personal competencies in an actualhospital clinical area under simulated conditions

Delivery The programme will be delivered through formal presentations; problem based learning and practical clinical sessions in a relevant clinical setting; by a qualified faculty with defining knowledge and experience.


Postgraduate Diploma in Clinical Education EduQual Level 7(38 credits)

Description This unit develops the knowledge and skills relevant to teaching and learning processes. The qualification establishes the set of professional competencies necessary to deliver structured, measured and effective teaching strategies. The programme identifies and assesses lecturing skills and the specific requirements for teaching clinical skills.

Assessment Criteria As a professional qualification, the key elements to be formally assessed are:

• Education theory• Effective Lecturing/Presentation Skills• Ability to instruct participants to teach effectively• Teaching a Clinical Skill• Education Session Plan

This unit will be assessed through four different activities. Participants will be asked to:

• Deliver a lecture/lead a discussion• Teach a clinical or non-clinical skill• Appraise and critique (Positive feedback)• Complete written paper on course content

Delivery The programme will be delivered through formal presentations, structured delegate participation, and clinical skills sessions administered and facilitated by clinical educators with the defining experience and qualifications.

Healthcare Skills qualifications are awarded by EduQual with Training Qualifications UK an Ofqual recognized awarding organisation.

Due to the level of entry, and the number of hours required for continuous professional development, this course was approved by the awarding organization as commensurate with Level 7 qualifications within the UK.


Level Intellectual Skills & Attributes Processes Accountability

7 Display mastery of complex and specialised area of knowledge and skills.

Demonstrate expertise in highly specialised and advanced technical, professional and/or research skills.

Conduct research, or advanced technical or professional activity, using and modifying advanced skills and tools. Design and apply appropriate research methodologies. Communicate results of research to peers.

Develop new skills to a high level, including novel and emerging techniques. Act in a wide variety of unpredictable and advanced professional contexts.

Accept accountability in related decision making including use of supervision.

Take significant responsibility for the work of other professional staff; lead and initiate activity.

Level 7 QAA level descriptors A systematic understanding of knowledge, and a critical awareness of current problems and/or new insights, much of which is at, or informed by, the forefront of their academic discipline, field of study or area of professional practice.

• A comprehensive understanding of techniques applicable to their ownresearch or advanced scholarship

• Originality in the application of knowledge, together with a practicalunderstanding of how established techniques of research and enquiryare used to create and interpret knowledge in the discipline

Conceptual understanding that enables the student: • To evaluate critically current research and advanced

scholarship in the discipline• To evaluate methodologies and develop critiques of them

and, where appropriate, to propose new hypotheses

Typically, holders of the qualification will be able to: • Deal with complex issues both systematically and creatively, make sound judgments in the absence of complete data, and

communicate their conclusions clearly to specialist and non-specialist audiences

• Demonstrate self-direction and originality in tackling and solving problems, and act autonomously in planning and implementingtasks at a professional or equivalent level

• Continue to advance their knowledge and understanding, and to develop new skills to a high level

It is a pre-course requirement that delegates must be a qualified medic or have held a senior clinical role for five years. This course is a vocational qualification, enabling the delegates to improve their ability to present, instruct, and demonstrate clinical/ technical skills to others.

This meets the QAA (Qualifications Assurance Agency) for higher education equivalences of:


Description This unit develops the knowledge and skills relevant to arthroplasty which surgeons and hospital management expect of company personnel entering and supporting company products in Orthopaedic clinical areas.

This unit enables delegates to implement appropriate sales strategies to support and promote the safe use of company products.

Assessment Criteria As a professional qualification there are three key elements to be assessed:

• Technical knowledge - Anatomical structures, nomenclature and physics,implant design, bio mechanics, material sciences

• Orthopaedic specialist skills• Orthopaedic surgical principles and application

This unit will be assessed through four different activities:

• Verbal technical instruction exercises providing reasoned arguments fordecision

• Candidates will complete a multiple-choice questionnaire covering allaspects of the taught unit

• Clinical Role Play• Orthopaedic Science case study presentations

Delivery The programme will be delivered through formal presentations, problem based learning and practical clinical (bio skills) sessions administered and facilitated by clinical educators with the defining experience and qualifications.

Professional Diploma Orthopaedic Healthcare Industry EduQual Level 6


Postgraduate Diploma Human Factors in Clinical Settings EduQual Level 7 (38 Credits)

Description This unit develops the knowledge and skills required to have a basic understanding of Human Factors and their importance in Healthcare delivery. The qualification establishes the professional competencies necessary to identify the nature of Human Factors and develop strategies for individual Healthcare worker, alone and in a team, to use awareness of these factors to avoid common errors in the process of care.

The programme builds on the Post Graduate Diploma in Clinical Education, using many of the skills from that course in its delivery. It specifically tests and improves the delegates' understanding of what human factors are and shows how understanding human interactions can lead to improved outcomes for patients.

Assessment Criteria As a professional qualification there are four key elements to be formally assessed:

• What are Human Factors?• How do they impact on Healthcare Delivery?• How do delegates use this knowledge to avoid errors in care?• How will delegates teach these elements to other Healthcare professionals?

This unit will be assessed through four different activities. Participants will be asked to:

• Deliver a lecture/lead a discussion on Human Factors• Identify changes in practice based on an understanding of Human Factors• Produce a plan to introduce changes based on course content• Complete a knowledge based examination on course content

Delivery The programme will be delivered through formal presentations, structured delegate participation and administered and facilitated by clinical educators with the defining experience and qualifications. There will be a formal test of knowledge of Human Factors.


Description This course develops the knowledge and skills required to have a basic understanding of Human Factors and Resilience, and their importance in the commercial environment.

The qualification establishes the professional competencies necessary to identify the nature of Human Factors and Resilience and develop strategies for the individuals, alone and in a team, to use awareness of these factors to maintain commercial success.

Objectives The objective of the Professional Certificate In Principles Of Resilient Selling in Clinical and Procurement Settings, is to explore what is required to successfully work as a sales professional within the complex and dynamic environment of healthcare and the NHS and to improve the chances of commercial success do to an increased understanding of the role of procurement and the manner in which hospitals want to buy.

The key elements will:

• examine the basic understanding of Human Factors and their importance in managing successfulclinical and commercial relationships

• establish the professional competencies necessary to identify the nature of human factors anddevelop strategies for working both alone and in a team

• use awareness of these factors to avoid common error in the command process• enable the delegate to develop decision making strategies taking into account Human Factors and Resilience

This module will also cover Situational awareness, organisational and management factors, leadership models, concepts and tools.

Assessment Criteria As a professional qualification there are four key elements to be assessed:

• What are Human Factors and Resilience?

• How do they impact on Healthcare Delivery?

• How do delegates use this knowledge to avoid errors in care?

• How will delegates teach these elements to other Healthcare professionals?

This qualification will be assessed through four different activities. Participants will be asked to:

• Deliver a lecture/lead a discussion on Human Factors and Resilience

• Identify changes in practice based on an understanding of Human Factors andResilience

• Produce a plan to introduce changes based on course content

• Complete a knowledge based examination on course content

Delivery The programme will be delivered through formal presentations, structured delegate participation and administered and facilitated by clinical educators with the defining experience and qualifications. There will be a formal test of knowledge on the science and application of Human Factors and Resilience.

Professional Certificate in

EduQual Level 5


Professional Certificate in Principles Of Healthcare Procurement EduQual Level 5

Description This course is delivered by qualified procurement and healthcare industry professionals. The focus is to provide the knowledge and skills relevant to the management of sales processes and approaches. This qualification identifies competencies that will result in a strategy for a successful sales approach.

Objectives The objective of the Professional Qualification in Principles Of Clinical Procurement, is to explore the structure and strategy required for commercial success with your company product portfolio. To know and understand the procurement process and to identify an approach which matches the Hospital procurement cycle.

The outcome of the course will enable the participants to;

• know and understand the purchasing environment of the healthcare sector• understand the restrictions, processes and initiative that the hospital

personal are bench marker to.• Effectively represent your organisation by understanding the legal and

regulatory environment for procurement• Promote how your company improves patient outcomes and develop a planned

approach by the way hospitals want to buy

Assessment Criteria As a professional qualification there are three key elements to be assessed: • Technical Knowledge• Specialist Skill• Reflective Practice

This qualification will be assessed through four separate activities:

• Candidates will complete a written assessment relevant to theprocurement landscape

• Candidates will complete a multiple-choice questionnaire covering allaspects of the taught programme

• Candidates will demonstrate their understanding of the principles ofcommercial healthcare in a short (5 Mins) discussion

• Candidates will complete a Risk Management Exercise with reference toactivity in the Healthcare commercial sector


Description This unit develops a detailed understanding of the central tenet of ethical behavior in a promotional pharmaceutical environment.

The programme enables delegates to develop and enhance their knowledge of the UK Code of Practice, skills and attitudes, to ensure safe and ethical promotional activities.

• Structures and supply routes; a code of conduct for healthcare salesprofessionals; the key legal and regulatory factors impacting the role

• Plan: A resilient approach to the management of sales and commercialrelationships within the healthcare environment with the primary objective ofimproving patient outcomes

Assessment Criteria As a professional qualification there are three key elements to be assessed:

• Technical knowledge of the Code of Practice• Reflective Practice• Risk Management

This unit will be assessed through three different activities. Participants will be asked to:

• Deliver verbal feedback throughout• Complete a multiple-choice questionnaire covering all aspects of the

taught unit• Complete a written paper on an item of course content

Delivery The programme will be delivered through formal presentations, structured delegate participation, and practical sessions administered and facilitated by clinical educators with the defining experience and qualifications.

Professional Certificate In Fundamentals of Pharmaceutical Ethics and The UK Code of Practice EduQual Level 6 Professional Customised Short Course


MEDICAL DEVICE REGULATIONS COURSES



Description This unit develops:

• Learners’ academic knowledge and critical awarenessof the issues that comprise the Medical DeviceRegulations

• Understanding of how regulatory requirements affectbusiness practice

• Applications to protect and sustain the companyactivities in their area of responsibility

• Determine appropriate compliance pathways,technical requirements and data

• Understanding of Quality Management Systems inrelation to the Medical Device Directive

Assessment Criteria As a professional qualification there are three key elements to be met:

• Technical Knowledge• Regulatory Process Skills• Reflective Practice


• Candidates will complete a comprehensive written assessmentwhich will include the regulatory principles applied to the riskmanagement of the company commercial activity

• Candidates will complete a multiple-choice questionnaire coveringall aspects of the taught Regulatory unit and it’s pre-course reading

• Candidates will be expected to demonstrate personal competenciesin the business environment

Delivery The programme will be delivered online with online assessment.

Medical Device Regulations Award EduQual Level 5


Description This qualification will create Regulatory Medical Device professionals equipped with the technical knowledge, implementation skills and professional attitudes to deliver the highest standards of Healthcare Compliance in the Medical Devices sector of Life Sciences.

• The aim of the Professional Certificate inMedical Devices is to develop academic knowledgeand critical awareness of the issues which comprisethe Medical Device Regulations, and to develop theirunderstanding of how commercial ventures may giverise to legal issues

• The regulations and laws will be studied in relation tohow they are applied

Assessment Criteria The assessment process has been designed to ensure that each assessment criterion covers the full range of issues taught on the programme. Under exam conditions candidates are required to demonstrate their knowledge of the issues, interpret that knowledge in reflective practice exercises and apply the knowledge and skills in a product development and approvals environment.

• Verbal Technical Instruction ExcerciseCandidates will complete verbal technical instruction assessment exercisesproviding reasoned arguments for decisions

• Risk Management Written ExcerciseCandidates will complete a written exercise demonstrating a QualityManagement system for the safe use and compliance of medical devices

• Short AssignmentCandidates will prepare a report for Verification, Validation and Post Market |urveillance of Medical Devices

• Multiple Choice Question PaperCandidates will complete a multiple-choice questionnaire covering all aspects ofthe taught units and the relevantpre-course reading personal competencies in an actual business environment

DeliveryThe programme will be delivered as a combination of online,3 days fully taught classroom training with pre-course reading andonline assessment.

Medical Device Regulations Professional Certificate EduQual Level 6


Medical Device Regulations Graduate Diploma EduQual Level 6

Description This qualification will create Regulatory Medical Device professionals equipped with the technical knowledge, implementation skills and professional attitudes to deliver the highest standards of Healthcare Compliance in the Medical Devices sector of Life Sciences. The Medical Device Regulations and the laws will be studied in relation to how they are applied.

Assessment Criteria The assessment process has been designed to ensure that each assessment criterion covers the full range of issues taught on the programme. Under exam conditions candidates are required to demonstrate their knowledge of the issues, interpret that knowledge in reflective practice exercises and demonstrate how to apply the knowledge and skills in a product development and approvals environment.

• Verbal Technical Instruction ExerciseCandidates will complete verbal technical instruction assessmentexercises providing reasoned arguments for decisions

• Risk Management Written ExerciseCandidates will complete a written exercise demonstrating a QualityManagement system for the safe use and compliance of medicaldevices

• Short AssignmentCandidates will prepare a report for Verification, Validation and PostMarket Surveillance of Medical Devices

• Multiple Choice Question PaperCandidates will complete a multiple-choice questionnaire covering allaspects of the taught units and the relevantpre-course reading personal competencies in an actual businessenvironment

Delivery The programme will be delivered as a combination of online, 4 days fully taught classroom training with pre-course reading and online assessment.

Entry

The Diploma is for Regulatory Professionals already involved in the legal aspects of medical device design, manufacture, sales and marketing. They will understand the basic tenet of medical devices directive and compliance with the local regulations in day to day commerce.


REASONS TO BELIEVE:

“The most important information I found concerned the unprepared rep’.”

“The ‘iceberg’ and how to approach it. What procurement want and need from industry.”

“Being prepared to do homework on the accountswillnot only help with the offer but also increase reputation within departments.”

“The medical device company has a role to play in facilitating the communications to look at complete patient pathway considerations and hospital-wide cost implications.”


“The view from procurement’s side of the desk. It is very rare we get such a frank insight from the ‘enemy’. It showed procurement is not the enemy at all – you just have to understand their role properly to work with them.”

“That there is an opportunity to work effectively with the changing landscape.”

OUR PARTNERS & TRAINING VENUES


HEALTHCARE SKILLS INTERNATIONAL ARE PROUD TO BE IN PARTNERSHIP WITH:

Royal College of Physicians and Surgeons Glasgow Cochlear UK & Europe

Computer Assisted Orthopaedic Surgery (CAOS, BOA) Barema

University of Madrid (Fannin, Medical Device Regulations) MATA

OUR TRAINING VENUES

GOLDEN JUBILEE NATIONAL HOSPITAL, National Waiting Times Centre Board, Golden Jubilee National Hospital, Beardmore Street, Clydebank, G81 4SA, UK.

ROYAL COLLEGE OF PHYSICIANS AND SURGEONS OF GLASGOW 232-242 St Vincent Street,Glasgow,G2 5RJ,UK.

LEITER HOTELLERIE, Spital und Gesundheitszentrum SANITAS, Grütstrasse 60, 8802 Kilchberg, Switzerland.

LA SALLE CENTRO UNIVERSITARIO C/ La Salle, 10, 28023 Madrid, Spain.

HOSPITAL NISA PARDO DE ARAVACA, La Salle, 12, 28023 Madrid, Spain.

HOSPITAL NISA 9 DE OCTUBRE, Valle de la Ballestera 59, 46015 Valencia, Spain.

NISA SEVILLA ALJARAFE HOSPITAL, Avda. Plácido Fernández Viagas, s/n 41950 Castilleja de la Cuesta Sevilla, Spain.

ADDENBROOKE’S HOSPITAL Cambridge University Hospitals, Hills Road, Cambridge, CB2 0QQ.


www.healthcareskills.com

Copyright© Diane Irvine 2000 (Updated 2019)

Copyright© Diane Irvine 2000 (Updated 2019) 40 Issue 2 (15082019)

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