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Breakfast SeminarWhat can we expect in the new revision of the ISO 14971 standard?
Cristina.Barkman@QAdvis.com,+46 704 88 88 19
Bar 2018
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QAdvis – Key competence areas
QMS In-the-cloudTurn Key QMSDigital SignaturesEfficient and Lean
System DevelopmentProduct Software ValidationComputer Systems ValidationRisk ManagementVerification and ValidationProcess Validation
QA&RA/Clinical ConsultingInterim Management, Expert Advise Audits/Mock audit/Due DiligenceWarning Letters, Compliance ProjectsPMA, 510k, CE-Marking, Tech FilesGlobal Regulatory SupportVigilance, Recalls, PMSClinical Evaluation and Clinical Studies
Training/CoursesCE-Marking, MDR, IVDRISO 13485 & QSR & MDSAPIEC 62304 & IEC 82304-1IEC 60601-1IEC 62366-1Risk Management And more…
Agile, Lean and Six SigmaTraining and consultingin cooperation with US partner
European Authorised RepresentationProviding European representation for non-EU MedTech companiesActive member of EAAR(European Association of Authorized Reps)
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Presentation of the speaker Cristina Barkman• >20 years experience from
development & manufacture of medical devices
• Extensive experience from risk management for medical devices
• Member of the standardization committee ISO/IEC TC210 JWG1
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Agenda
• Standardization process• Timeline• Main changes in ISO 14971• Main changes in ISO/TR 24971• Take away notes
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Standardization process
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Standardization Process - ISO TC 210
TC 210
JWG 4
JWG 3
JWG 2
JWG 1
WG 2
WG 3
WG 6
WG 5
WG 1
AHGWG 6WG 666
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Standardization process –JWG 1
• Joint work group with IEC• Responsible for medical device
risk management• Author of ISO 14971 and ISO TR
24971• Members – NB, FDA, competent
authorities, industry representatives
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Standardization process - Assignment
• 2016 revision process started
• Risk management process not to be revised
• A requirement to move most informative annexes to ISO/TR 24971
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Timeline
2016Project
started in Tampa (US)
2017Delft (NL)
Hiroshima (JP)
2018London (UK)
Long Beach (US)Seoul (KR)
2019Expected release of ISO 14971
2020Expected release of
ISO/TR 24971
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Main changes in ISO/DIS 14971
• Clauses restructured and revised• Most annexes moved to
ISO/TR 24971• Process applicable for all types of
medical device risks• Defined terms updated• Normative clause added
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Key changes: Benefit-Risk
• Definition of benefit added• Aligned terminology• Benefits expected from use
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Key changes: Overall residual risk
• Method to be defined in the plan.• Criteria for its acceptability defined
in the plan.• Criteria can be different from the
criteria for acceptability of individual risks.
• Disclosure of residual risk
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Key changes: Risk management review
• Clarified that the review concerns the execution of the risk management plan.
• The results documented as the risk management report
• Plan for subsequent reviews and updates of RMR
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Key changes: Production and post-production activities
• More detail on information to be collected and reviewed.
• More detail on actions to take when the information is determined to be relevant to safety.
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Key changes: AnnexesISO 14971:2007 ISO 14971:2019
Annex A Rationale for requirements Annex A Rationale for requirements
Annex B Overview of the risk management process for medical devices
Annex B Overview of the risk management process for medical devices
Annex C Questions that can be used…Moved to ISO/TR 24971
Annex D Risk concepts applied to medical …
Annex E Examples of hazards, … Annex C Fundamental risk concepts
Annex F Risk management plan
Moved to ISO/TR 24971
Annex G Information on risk mgm techniques
Annex H Guidance on risk mgm for in-vitro …
Annex I Guidance on risk analysis process…
Annex J Information for safety and about …(c((c)
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analysis pro
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Harmonization with European directives and regulations
• Harmonization done by the European Commission
• No timeline for harmonization yet• Proposal for Annexes Z by JWG 1
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Main changes in ISO/TR CD2 24971• Developed in parallel with the
revision of ISO 14971.• Comprises the chapters of
ISO/TR 24971:2013 • Includes most annexes of
ISO 14971:2007• Entire document restructured, revised
and supplemented. • NEW Annex on risks related to
cybersecurity(c) 20
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Cybersecurity risks
• Process also suitable for cybersecurity risks
• Correspondence between terms• Overlapping between health risks
and cybersecurity risks
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Main changes: Overview of new structureCONTENT
1 Scope 10 Production and post-production activities
2 Normative references Annex A Identification of hazards and characteristics for safety
3 Terms and definitions Annex B Risk analysis techniques
4 General requirements for risk management Annex C Risk acceptability considerations
5 Risk Analysis Annex D Information for safety and information on residual risk
6 Risk Evaluation Annex E Role of international standards in risk management
7 Risk Control Annex F Guidance on risk related to cybersecurity
8 Evaluation of residual risk Annex G Components and devices designed not using ISO 14971
9 Risk management review Annex H Guidance for in-vitro diagnostic devices(c)(c)
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Take away notes
• No risk management revolution!• Keep informed• Train• Prepare your processes & files
2018
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formeainepare
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QAdvis services
Implementation of QMS
Development of product documentation
Risk management/Clinical evaluation
Software validation
Training
Implementation of tools
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