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1Copyright 2012 ITRI 工業技術研究院
1
Medical Device Quality Management System
Albert T.W. LiIndustrial Technology Research Institute
AHWP TC Training Workshop, TaipeiNovember 3, 2012
2Copyright 2012 ITRI 工業技術研究院
GHTF Medical Device Regulatory Model
QMS for SMEs
Revision of ISO 13485
Content
3Copyright 2012 ITRI 工業技術研究院
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/Risk Analysis
QMS Design Control/ Risk Assessment
Labelling
QMS Design Validation/Risk Assessment/ Process
Validation
QMS
QMS Service
Device Classification
Conformity Assessment Approval Registration/ Licencing
Post Market Surveillance and Vigilance
Adverse Event Reporting
QMS
Clinical Evidence
4Copyright 2012 ITRI 工業技術研究院
GHTF Medical Device Regulatory Model
QMS for SMEs
Revision of ISO 13485
Content
5Copyright 2012 ITRI 工業技術研究院
• Economic growth in the medical device industry is fueled by new product development. Furthermore, a significant proportion of that new product development comes from small and emerging companies.(Centers for Medicare & Medicaid Services, HHS, U.S., Market Update Reports, 2003)
• Taiwan: 1,034 Class I MD manufacturers, 506 Class II/II MD manufacturers , 30,000 employees
• U.S: 5,300 MD manufacturers, 365,000 employees, 15% manufacturers with more than 100 employees, 73% manufacturers with employees less than 20
• EU: 8,750 MD Manufacturers, 534,000 employees, 80% manufacturersare SMEs (1,187 manufacturers with 50~250 employees, 1,940 manufacturers 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
6Copyright 2012 ITRI 工業技術研究院
6
QMS and Medical Device Safety and Effectiveness
• The (GMP/QS) regulation requires• that various specifications and controls be established for
devices;• 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 medical devices are safe and effective for their intended use.
US FDA Medical Device Quality Systems Manual
7Copyright 2012 ITRI 工業技術研究院
7
Medical Device QMS Standards
• 1978 US FDA 21 CFR 820 Medical Device Good Manufacturing 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
8Copyright 2012 ITRI 工業技術研究院
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 Manufacturers CMDCAS, GMP, EN ISO 13485: 2003
EuropeanUnion
AIMD/MDD/IVDD
Notified Bodies
Health CanadaEU
CompetentAuthorities
US 21 CFR 820MDUFMA
FDA QSRAccredited
Persons
US FDA CDRHTPRB
TaiwanPAA, GMP
GMPAuthorized
AuditingOrganizations
TFDA
9Copyright 2012 ITRI 工業技術研究院
ISO 13485:2003
7.1Planning of
product realization
7.Product Realization
7.2Customer-related
processes
7.3Design
And development
7.4 Purchasing
7.5Production and service
provision
4.1General
requirements
4. QMS
4.2Documentation
5.1ManagementCommitment
5.Management Responsibility
5.2Customer
Focus
5.3QualityPolicy
5.4Planning
5.6Managementresponsibility
5.5Responsibility
Authority,Communication
6.1Provision
of resources
6.Resource Management
6.2Human
resources
6.3infrastructure
6.4Work
environment
7.6Control
Of monitoringand measuring
devices
7/8Measurement, analysis and improvement
8.1General
8.2Monitoring
andmeasurement
8.3control of
Non-conforming
product
8.5improvement
8.4Analysisof data
10Copyright 2012 ITRI 工業技術研究院
ISO 13485 Subsystems
Design and Development
Product Documentation
Purchasing Control
Production and Manufacturing
Management CAPA Document and Record
CustomerRelated
Product Related Subsystems
Supporting Subsystems
GHTF/SG4/N30R21:2010 Part 2: Regulatory Auditing Strategy
11Copyright 2012 ITRI 工業技術研究院
Further Readings: Standards and GHTF Guidance
ISO/TC 176/SC 2/N525R2, Introduction and support package: Guidance on the 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 to medical devices
ISO IEC 62366: 2007 Medical devices -- Application of usability engineering to 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 QMS processes
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 and Activities Within a Quality Management System
GHTF/SG3/N99-10 (Edition 2)Quality Management Systems - Process Validation Guidance
12Copyright 2012 ITRI 工業技術研究院
Further Readings: US FDA Guidance
Application to Device Good Manufacturing Practice Regulation to the Manufacturer 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 Risk
Management, 2000 Applying Human Factors and Usability Engineering to Optimize Medical
Device Design, 2011 Residual Ethylene Oxide in Medical Devices and Device Material
13Copyright 2012 ITRI 工業技術研究院
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
14Copyright 2012 ITRI 工業技術研究院
Key Points
4 QMS 4.2.1.1Docuementation4.2.1.4 MD Documentation
4.2.3.4 Electronic document4.2.3.5Rrecord retaining period
4.2.4. Record control
5.Management
responsibility
5.4.1 Quality objectives5.4.2 QMS planning
7. Product realization
7.1.1.5 Product requirements7.1.2 risk management7.1.3expiration date
7.3 Design and development
7.4.1 Purchasing process
6.4 Work environment6. Resource management
7.5.1 Control of production and service provision
7.5.2 Validation of processes for production and service provision
8. Measurement, analysis, and improvement
8.1.2, 8.1.3 Statistical methods
8.5 Improvement
8.2.4 Monitoring and measurement of product
7.6 Control of monitoring and measuring devices制
15Copyright 2012 ITRI 工業技術研究院
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) Particular
requirements for active implantable ad implantable devices
16Copyright 2012 ITRI 工業技術研究院
Design and Development Process
User Needs
Design Input
Design Process
Design Output
Medical Device
Design Review
Design Validation
Design Verification
• DHF/Technical Documentation
• Premarket Submission (ex. STED)
21 CFR 820.30 Quality System RegulationISO 13485: 2003 7.3
17Copyright 2012 ITRI 工業技術研究院
Integrated Design ProcessDESIGN CONTROL SYSTEM OUTLINECHANGE 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
REV
IEW
(e)
DHF (j)
VER
IFIC
ATI
ON
(f)
DA
TA F
OR
MA
RK
ETIN
GSU
BM
ISSI
ON
S
INTEGRATED CHANGECONTROLPROCEDURE
- CHANGE REQUEST- FORMS- ID OF DOCUMENTS- REVISION LEVELS- TIMELY
"EXTERNAL"REQUEST
integrated_change_ctrl.doc
ISO 14971: 2007 Medical Devices –Application of risk
management to medical devices
ISO IEC 62366: 2007 Medical devices –
Application of usability engineering to medical
devices
IEC 62304:2006 Medical device software -Software life cycle
processes
18Copyright 2012 ITRI 工業技術研究院
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
19Copyright 2012 ITRI 工業技術研究院
Medical Device Hazards
19IEC 14971:2007, Table E.1 — Examples of hazardshttp://www.nhlbi.nih.gov/
Bio
log
ical and
chem
ical h
azards
Energ
yh
azards
Operational Hazards
Information hazards
Function Use error Electromagnetic energyBiological
Labeling Operatinginstructions Warnings Radiation
energy
Chemical
Biocompatibility
Thermal energy
Mechanical energy
Medical Device
20Copyright 2012 ITRI 工業技術研究院
GHTF Medical Device Regulatory Model
QMS for SMEs
Revision of ISO 13485
Content
21Copyright 2012 ITRI 工業技術研究院
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 countries in 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 a revised standard.
Revision of ISO 13485
22Copyright 2012 ITRI 工業技術研究院
Compatibility with Regulations and Standards
• To converge its requirements further with those in the U.S. FDA
21 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)
23Copyright 2012 ITRI 工業技術研究院
Subjects to Be Addressed in the Text of the Amended Standard
• Focus on QMS requirements, not product requirements, and to emphasize that the QMS requirements in the standard apply throughout the life cycle of the products
• Product lifecycle management (ISO 15288[System life cycle processes] and ISO 12207[Software life cycle processes])
• Software validation requirements such as QMS software and medical device software
• 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, complaint handling, returned product handling, and CAPA (GHTF SG3 N18 )
• Design and development requirements linked to essential requirements, V&V protocols and so on.
• Environmental control, process validation (GHTF SG3/N99-10 ed. 2)
• Record retaining time
• Annex Z of EN 13485
24Copyright 2012 ITRI 工業技術研究院
Enhance QMS
24
1. Enhanced operating systems1) Design and reliability engineering – specifically, validation of actual
product use, design-for-reliability and manufacturability, and software robustness.
2) Robust postproduction monitoring and feedback into design and manufacturing that goes beyond base compliance requirements.
3) Supplier management processes, particularly in material and process change 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 and incentivized around quality performance.
3. Enhanced mindsets and behaviors1) Quality culture can be improved where companies have experienced
severe quality-related issues.
US FDA, Understanding Barriers to Medical Device Quality, Oct 31, 2011
25Copyright 2012 ITRI 工業技術研究院
Thank you very much
Albert T.W. LiTel: +886-3-573-2227Fax: +886-3-573-4092E-mail: [email protected]
Science Industrial Park, Hsinchu