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7/21/2019 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
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GHTF Medical Device Regulatory Model
QMS for SMEs
Revision of ISO 13485
Content
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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
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GHTF Medical Device Regulatory Model
QMS for SMEs
Revision of ISO 13485
Content
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• 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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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GHTF Medical Device Regulatory Model
QMS for SMEs
Revision of ISO 13485
Content
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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.
Revision of ISO 13485
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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)
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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
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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
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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