FOUNDATION COURSE

ON ISO 13485:2016

Course Provider: Carmel McGrath

AlphaMed Consulting Ltd in partnership with Irish Medtech Skillnet.

Program Deliverables:

Provide understanding of ISO 13485:2016 Standard with specific focus on new additions, changes and associated implications for Industry. Ensure transition timelines and methods to bridge gaps are understood.

Session Topic Deliverables

8.30 – 10.30 Introductions – Presenter & Participants

Ø Introduction to Regulations and Standards for Med. TechØ Overview of regulatory structure; Notified Body, Competent Authorities.Ø ISO 13485: 2016 – specifically for Medical Devices, path to

o New Certificationo Transition from ISO 13485: 2003/2012

Thorough understanding of the history of regulations, standards & where we are today in Medical Technology Industry.

10.30 – 10.45 Break10.45 – 12.45 Up-skill on ISO13485: 2016 standard – interactive session

Ø ISO 13485: 2016 IQ quizØ What has changed from previous revision?Ø Similarities & DifferencesØ Clarity on definitions, terms & expectationsØ Let’s do Gap Analysis

Detailed insight into the major changes in ISO13485: 2016 and how to manage business impact.

12.45 – 1.30 Lunch1.30 – 3.30 Integrated QMS & Business process

Ø Where to start!Ø Dealing with what’s new & clarifiedØ 5 step transition plan Ø Key Stakeholders Ø Your Notified Body interactions – what to expect

Appropriate knowledge and understanding to demonstrate capability & manage site inspection.

3.30 – 3.40 Break3.40 – 5.30 Application of risk based thinking to QMS

Ø What do we know about ISO 14971Ø How to deal with outsourced processesØ ISO 13485:2016 – Key takeaways!Ø Q&AØ Course Evaluation form

Understanding concepts of risk management including introduction to standard and relevant QMS interface.

Carmel McGrath - Biography

¨ Carmel is a highly motivated, competent professional with significant experience (25+ years) in theMedical Device Industry. Her Regulatory knowledge along with her Quality experience positionsher well to support key projects in the Life Science Industry. Carmel has vast regulatory experiencewith PMA, design dossier and technical file review changes. She has been regularly contracted toresearch and compile Clinical Evaluation Reports (CER's) and enjoys applying her knowledgeespecially in Post Market Surveillance reports. She has held responsibility for Post MarketSurveillance (complaints) including U.S. MDR/Vigilance and associated product investigation etc.with feedback to design process throughout her career. Carmel holds a BA & Masters in RA fromSt. Cloud State, Minn.

¨ Most recently, Carmel has dedicated a significant portion of her time to developing and educating for the sector which is critical to meet the industry need. In conjunction with the Irish Medtech Skillnet Association, Industry Regulatory Steering group and Limerick University, she has been to the forefront in designing and delivering direct training to ensure the Fundamentals of Regulatory Affairs are understood by aspiring regulatory professionals. This programme is now also one of the key modules in the new UL BSC Level 8 degree in Regulatory Affairs.

¨ In addition, Carmel continues to provide support to industry providing contract services primarily inregulatory, quality and education areas. Continuous education is paramount in her personaldevelopment and she is in final year of her Master's degree in RA while also expanding herknowledge in the Pharmaceutical and IVD requirements. Carmel promotes the increased focus thatregulators require on risk management and its application throughout the product and qualitysystem processes and provides training in this area also.

¨ In her time in Industry primarily with Medtronic, the Galway site held the highest compliance ratingacross the Corporation. She encouraged & instigated a high compliance expectation throughout theorganization and implemented successful training programmes to ensure site success. Carmel heldvarying roles of management responsibility reporting in parallel to the site Quality Director,Corporate QA Head and Regulatory Affairs Leadership. She has vast experience dealing withGlobal Regulatory Authorities including FDA, Notified Body agencies (i.e. BSI, NSAI & TUV)European Competent Authorities along with Canadian, & TGA Australia.