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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

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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

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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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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

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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

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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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