Medical device iso 13485

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1Copyright 2012 ITRI 工業技術研究院

1

Medical Device QualityManagement System

Albert T.W. Li

Industrial Technology Research Institute

AHWP TC Training Workshop, TaipeiNovember 3, 2012




GHTF Medical Device Regulatory Model

QMS for SMEs

Revision of ISO 13485

Content




Medical Device Regulation ModelRef. GHTF/AHWG-GRM/N1R13:2011 Global Harmonization Task Force with modifications

Product Lifecycle Start

Device Requirements /Intended Use

Design Input/Specifications

Design

Design Verification

Pilot Production

Design Validation

Manufacturing

Placing on the Market

Market Performance

Obsolescence

Product Lifecycle End

Definitions

The Essential Principles/Standards

QMS Design Control/RiskAnalysis

QMS Design Control/ RiskAssessment

Labelling

QMS Design Validation/RiskAssessment/ Process

Validation

QMS

QMS Service

Device Classification

Conformity Assessment ApprovalRegistration/ Licencing

Post Market Surveillanceand Vigilance

Adverse Event Reporting

QMS

Clinical Evidence





QMS for SMEs


Content




• Economic growth in the medical device industry is fueled by new

product development. Furthermore, a significant proportion of that newproduct development comes from small and emergingcompanies.(Centers for Medicare & Medicaid Services, HHS, U.S.,Market Update Reports, 2003)

• Taiwan: 1,034 Class I MD manufacturers, 506 Class II/II MDmanufacturers , 30,000 employees

• U.S: 5,300 MD manufacturers, 365,000 employees, 15% manufacturerswith more than 100 employees, 73% manufacturers with employees lessthan 20

• EU: 8,750 MD Manufacturers, 534,000 employees, 80% manufacturersare SMEs (1,187 manufacturers with 50~250 employees, 1,940manufacturers with 10~50 employees, 3,702 manufacturers with

employees less than 10• UK: 3,000 MD manufacturers , 98% manufacturers with employees less

than 100, 65% manufacturers with employees less than 10.

Medical Device Innovation Engine: SMEs




6

QMS and Medical DeviceSafety and Effectiveness

• The (GMP/QS) regulation requires

• that various specifications and controls be established fordevices;

• that devices be designed under a quality system to meet

these specifications;

• that devices be manufactured under a quality system; that

finished devices meet these specifications;• that devices be correctly installed, checked and serviced;

• that quality data be analyzed to identify and correct quality

problems; and

• that complaints be processed.

• Thus, the QS regulation helps assure that medicaldevices are safe and effective for their intended use.

US FDA Medical Device Quality Systems Manual




7

Medical Device QMS Standards

• 1978 US FDA 21 CFR 820 Medical Device GoodManufacturing Practice

• ISO 9001: 1987

• ISO 9001: 1994, ISO 9002: 1994, ISO 9003: 1994, ISO 9004:

1994

• ISO 13485: 1996, ISO 13488: 1996 (based on ISO 9001: 1994,ISO 9002: 1994)

• 1996 US FDA Quality System Regulation/GMP

• ISO 9001: 2000

• ISO 13485: 2003 (stand alone standard)

• ISO 9001: 2008




Regulatory Auditing

8

AccreditationOrganizationsISO/IEC 17011

Certification Regulatory Auditing (examples)

QMS Certification Bodies(ISO/IEC 17021)

MD ManufacturersISO 13485: 2003(ISO 9001: 2000

ISO 1400…)

CanadaMedicalDevice

Regulation

CMDCASRegistrars

Higher Risk MD ManufacturersCMDCAS, GMP, EN ISO 13485: 2003

EuropeanUnion

AIMD/MDD /IVDD

Notified Bodies

Health CanadaEU

Competent

Authorities

US21 CFR 820MDUFMA

FDA QSRAccredited

Persons

US FDA CDRHTPRB

TaiwanPAA, GMP

GMPAuthorized

AuditingOrganizations

TFDA




ISO 13485:2003

7.1Planning of

productrealization

7.Product Realization

7.2Customer-related

processes

7.3Design

Anddevelopment

7.4Purchasing

7.5Productionand service

provision

4.1General

requirements

4. QMS4.2

Documentation

5.1ManagementCommitment

5.Management Responsibility5.2

CustomerFocus

5.3QualityPolicy

5.4Planning

5.6Managementresponsibility

5.5Responsibility

Authority,Communication

6.1

Provisionof

resources

6.Resource Management

6.2Human

resources6.3

infrastructure6.4Work

environment

7.6Control

Of monitoringand measuring

devices

7/8Measurement, analysis and improvement

8.1General

8.2

Monitoringand

measurement

8.3control of

Non-conforming

product

8.5improvement

8.4Analysisof data




ISO 13485 Subsystems

Design andDevelopment

ProductDocumentation

PurchasingControl

Production andManufacturing

Management CAPA Documentand Record

CustomerRelated

Product Related Subsystems

Supporting Subsystems

GHTF/SG4/N30R21:2010 Part 2: Regulatory Auditing Strategy




Further Readings:Standards and GHTF Guidance

ISO/TC 176/SC 2/N525R2, Introduction and support package: Guidance onthe documentation requirements of ISO 9001:2008

ISO/TR 14969:2004 Medical devices -- Quality management systems --Guidance on the application of ISO 13485: 2003

ISO 14971: 2007 Medical devices -- Application of risk management tomedical devices

ISO IEC 62366: 2007 Medical devices -- Application of usability engineeringto medical devices

ISO IEC 62304: 2006 Medical device software -- Software life cycle processes

GHTF/SG3/N18/2010 Quality Management System - Medical Devices -Guidance on corrective action and preventive action and related QMSprocesses

GHTF/SG3/N17/2008 Quality Management System - Medical Devices -Guidance on the Control of Products and Services Obtained from Suppliers

GHTF/SG3/N15R8/2005 Implementation of Risk Management Principles andActivities Within a Quality Management System

GHTF/SG3/N99-10 (Edition 2)Quality Management Systems - ProcessValidation Guidance




Further Readings:US FDA Guidance

Application to Device Good Manufacturing Practice Regulation to theManufacturer of Sterile Devices, 1982, 1983

Guideline for the Manufacture of In Vitro Diagnostic Products, 1994

Bacteria Edotoxins/Pyrogens, 1995

Guide to Inspections of Foreign Medical device Manufacturers, 1995

21 CFR 801.415 Maximum acceptable level of ozone

Guide to Inspections Validation of Cleaning Processes

Electromagnetic Compatibility Aspects of Medical Device Quality Systems Medical Device Quality Systems Manual: A Small Entity Compliance Guide,

1996

Do It by Design, 1996

Design Control Guidance for Medical Device Manufacturers, 1997

Medical Device Use-Safety: Incorporating Human Factors Engineering into RiskManagement, 2000

Applying Human Factors and Usability Engineering to Optimize MedicalDevice Design, 2011

Residual Ethylene Oxide in Medical Devices and Device Material




ISO/TR 14969: 2004

• ISO/TR 14969: 2004 Medical devices — Quality management

systems — Guidance on the application of ISO 13485:2003

• ANSI/AAMI/ISO TIR14969:2004 Medical devices—Quality

management systems— Guidance on the application of ISO

13485:2003

• 医疗器械质量管理体系YY／T0287-2003应用指南

• CEN ISO/TR 14969:2005




Key Points

4 QMS 4.2.1.1Docuementation

4.2.1.4 MDDocumentation

4.2.3.4 Electronicdocument4.2.3.5Rrecordretaining period

4.2.4. Record control

5.Management

responsibility

5.4.1 Quality objectives5.4.2 QMS planning

7. Productrealization

7.1.1.5 Product

requirements7.1.2 risk management7.1.3expiration date

7.3 Design anddevelopment

7.4.1 Purchasing process

6.4 Work environment6. Resourcemanagement

7.5.1 Control ofproduction and serviceprovision

7.5.2 Validation ofprocesses forproduction and serviceprovision

8. Measurement,analysis, andimprovement

8.1.2, 8.1.3 Statisticalmethods

8.5 Improvement

8.2.4 Monitoring andmeasurement ofproduct

7.6 Control ofmonitoring andmeasuring devices制




No Specific Guidance Given inISO TR 14969: 2004

• 3 Terms and definition

• 4.2.2 Quality manual

• 5.2 Customer focus

• 6.2.1 (Human resources) General

• 7.2.2 Review of requirements related to the product

• 8.2.3 (Monitoring and measurement of processes)

Monitoring and measurement of processes

•8.2.4.2 (Monitoring and measurement of product) Particularrequirements for active implantable ad implantable devices




Design and Development Process

User Needs

Design Input

Design Process

Design Output

Medical Device

Design Review

Design Validation

Design Verification

• DHF/TechnicalDocumentation

• PremarketSubmission (ex.STED)

21 CFR 820.30 Quality System RegulationISO 13485: 2003 7.3




Integrated Design ProcessDESIGN CONTROL SYSTEM OUTLINE

CHANGE INTEGRATED INTO DESIGN CONTROL

GENERAL820.30 (a)

PLANNING (b)

INPUT (c)

OUTPUT (d)

-----------------------------DMR 820.181

TRANSFER (h)

INITIALPRODUCTION

VERIFICATION (f)& VALIDATION (g)

TRANSFER (h) FORFULL-SCALEPRODUCTION

R E V I E W

( e )

DHF (j)

V E R I F I C A T I O

N ( f )

D A T A

F O R

M A R K

E T I N G

S U B M I S S I O N S

INTEGRATED CHANGECONTROLPROCEDURE

- CHANGE REQUEST

- FORMS- ID OF DOCUMENTS- REVISION LEVELS

- TIMELY

"EXTERNAL"REQUEST

integrated_change_ctrl.doc

ISO 14971: 2007Medical Devices –Application of risk

management tomedical devices

ISO IEC 62366: 2007

Medical devices –Application of usabilityengineering to medical

devices

IEC 62304:2006 Medicaldevice software -

Software life cycleprocesses




Medical Device Risk Management

Risk Analysis•Intended use and identification of characteristics

related to the safety of the medical device•Identification of hazard

•Estimation of the risk(s) for each hazardous situation

Risk Analysis•Intended use and identification of characteristics

related to the safety of the medical device•Identification of hazard

•Estimation of the risk(s) for each hazardous situation

Production and post-production informationProduction and post-production information

Risk Evaluation•Risk tolerability decisions

Risk Evaluation•Risk tolerability decisions

Risk Management

Risk Assessment

Risk Control•Risk control option analysis

•Implementation of risk control measures•Residual risk evaluation

•Risk/benefit analysis•Risk arising from risk control measures

Risk Control•Risk control option analysis

•Implementation of risk control measures•Residual risk evaluation

•Risk/benefit analysis•Risk arising from risk control measures

Evaluation of overall residual risk acceptabilityEvaluation of overall residual risk acceptability

Risk management reportRisk management report




Medical Device Hazards

19

IEC 14971:2007, Table E.1 — Examples of hazards http://www.nhlbi.nih.gov/

B i ol o gi c a

l an d c h emi c

al

h

az ar d s

E n er g yh az ar d s

Operational Hazards

Information hazards

Function Use errorElectromagnetic

energyBiological

LabelingOperatinginstructions

WarningsRadiation

energy

Chemical

Biocompatibility

Thermal energy

Mechanicalenergy

Medical Device





QMS for SMEs


Content




In 2009 ISO/TC 210, Working Group 1 considered

the need for revision of ISO 13485:2003

Prompted by the emergence of new national

medical device regulatory activities from countriesin the South American and Asian Pacific regions, in

2011 the Working Group conducted a formal user

survey to determine the need for a revised standard

and to provide insight into the content of such arevised standard.





Compatibility with Regulations andStandards

•To converge its requirements further with those in the U.S. FDA21 CFR Part 820, the Japanese MHLW Ministerial Ordinance No.

169: 2004, and the conformity assessment requirements of the

European medical device legislation, while not intending to

compensate for the deficiencies of such national and regional

regulations.

• To address developments in regulatory requirements for QMS

in other jurisdictions.

• To maintain requirements compatibility with ISO 9001:2008

(QMS) and ISO 9000:2005 (Fundamentals and vocabulary)




Subjects to Be Addressed in the Text of theAmended Standard

• Focus on QMS requirements, not product requirements, and to emphasize thatthe QMS requirements in the standard apply throughout the life cycle of the

products

• Product lifecycle management (ISO 15288[System life cycle processes] and ISO12207[Software life cycle processes])

• Software validation requirements such as QMS software and medical devicesoftware

• The roles and relationship between the organization and other parties in the

supply chain and outsourcing

• Risk management covering product lifecycle

• Postmarket information gathering and adverse event reporting, complainthandling, returned product handling, and CAPA (GHTF SG3 N18 )

• Design and development requirements linked to essential requirements, V&Vprotocols and so on.

• Environmental control, process validation (GHTF SG3/N99-10 ed. 2)

• Record retaining time

• Annex Z of EN 13485




Enhance QMS

24

1. Enhanced operating systems

1) Design and reliability engineering – specifically, validation of actualproduct use, design-for-reliability and manufacturability, and softwarerobustness.

2) Robust postproduction monitoring and feedback into design andmanufacturing that goes beyond base compliance requirements.

3) Supplier management processes, particularly in material and processchange controls.

2. Enhanced management infrastructure1) Quality metrics and measurement systems that go beyond regulatory

compliance measures.2) Quality organization that integrates cross-functionally throughout the

organization, rather than solely focused on compliance.3) Performance management, where those in key roles associated with

quality outcomes, like design engineers, are measured andincentivized around quality performance.

3. Enhanced mindsets and behaviors1) Quality culture can be improved where companies have experiencedsevere quality-related issues.

US FDA, Understanding Barriers to Medical Device Quality, Oct 31, 2011




Thank you very much

Albert T.W. Li Tel: +886-3-573-2227

Fax: +886-3-573-4092

E-mail: [email protected]

Science Industrial Park, Hsinchu

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