Mastering risk management according to ISO 14971:2019 — Principles and application to medical devices
Risk management is a fundamental regulatory obligation set out in Annex I (GSPR) of the MDR 2017/745 regulation. Yet it remains one of the most poorly documented activities in technical files submitted to notified bodies. This two-day training enables R&D, QA and RA teams to master the updated version of the ISO 14971:2019 standard, to build or audit a risk management file compliant with current regulatory expectations, and to apply analysis methods suited to their device families.
Audience R&D engineers, quality assurance (QA) managers, regulatory affairs (RA) officers, technical directors, project managers involved in the design or placing on the market of medical devices within the meaning of MDR 2017/745.
Learning objectives
- ▸ Distinguish the requirements of ISO 14971:2019 from the 2012 version and identify the structuring changes for risk management throughout the device life cycle
- ▸ Link the requirements of ISO 14971:2019 to the GSPR of Annex I of MDR 2017/745 and to the relevant clauses of ISO 13485:2016
- ▸ Build a compliant risk management plan, including acceptability criteria, the risk management policy and the risk management report
- ▸ Apply suitable analysis methods (product FMEA, FTA, HAZOP) to the identification and estimation of hazards and hazardous situations for a medical device
- ▸ Assess the overall residual benefit/risk ratio in accordance with the strengthened requirements of the 2019 edition and the expectations of notified bodies
- ▸ Integrate post-market surveillance (PMCF, PSUR, SSCP) into the feedback loop of the risk management process
Expected outcomes
- ✓ At the end of the training, the participant leaves with the skills needed to draft, update or audit a complete risk management file that can be defended before an ISO 13485 auditor or a notified body.
Accessibility & entry conditions
Access lead time
Registration up to 10 working days before the start of an open-enrolment session. In-house sessions can be scheduled within 3 to 4 weeks.
Prerequisites
Professional experience in the medical device sector (manufacturer, authorised representative, importer or distributor). Basic knowledge of MDR 2017/745 and/or ISO 13485 recommended. No formal prerequisite blocking enrolment.
Disability access
Any disability situation can be accommodated. Contact our officer before registration to explore possible adjustments (equipment, materials, pacing). Contact our officer →
Funding
- ·This training is not Qualiopi certified and cannot be funded via the OPCO
- ·Funding from own funds or the company's training budget
Detailed programme
A phone interview or positioning questionnaire is sent ahead of the session to calibrate the level, identify expectations and tailor the case studies to participants' real situations.
- 01
Foundations and developments of ISO 14971:2019 (2 h)
- ·Regulatory and normative context: the place of ISO 14971 within the MDR 2017/745, IVDR 2017/746 and ISO 13485:2016 ecosystem
- ·Structured comparison ISO 14971:2012 vs ISO 14971:2019: main changes, new definitions, strengthening of post-production requirements
- ·Links with the GSPR of Annex I of the MDR (general safety and performance requirements)
- 02
The risk management process: architecture and key documents (2 h 30)
- ·Risk management plan: required content, acceptability policy, objective criteria
- ·Identification of hazards and hazardous situations: sequences of events, intended use and reasonably foreseeable use
- ·Risk estimation and evaluation: matrices, severity and probability grids, acceptability thresholds
- ·Risk management report: structure, content, management review
- 03
Risk analysis methods: hands-on practice (3 h)
- ·Product FMEA applied to medical devices: step-by-step construction on a concrete case
- ·Introduction to FTA (Fault Tree Analysis) and HAZOP for complex systems
- ·Sub-group exercises: hazard identification, building the risk matrix, defining control measures
- ·In the in-house format, the case studies can be adapted to the client's device family
- 04
Risk control and benefit/risk evaluation (2 h)
- ·Selection and implementation of control measures: hierarchy of priorities (inherent safety, protective measures, information)
- ·Verification of the effectiveness of the measures
- ·Evaluation of residual risk and overall residual risk
- ·Residual benefit/risk analysis: strengthened requirements of the 2019 edition and expectations of notified bodies
- 05
Risk management in the post-production phase (2 h)
- ·Collection and analysis of post-market data: PMCF, field feedback, vigilance, PSUR
- ·Updating the risk management file during the product life
- ·Integration into the ISO 13485 QMS: link with CAPA and surveillance processes
- 06
Summary, assessment and questions and answers (2 h 30)
- ·Review of the two days; recap of the points of vigilance for a file defensible in audit
- ·End-of-training QCM
- ·Open question-and-answer session on participants' concrete situations
Assessment of learning
Assessment methods
QCM of 20 questions administered at the end of the second day, covering all the modules. The score obtained is communicated individually to each participant for information purposes. In the in-house format, a practical exercise on a case representative of the company's device may replace the QCM upon prior request.
Certificate
Training certificate issued by Isofac Group at the end of the training, subject to full attendance over the two days. This document specifies the objectives, content, duration and assessment methods followed. This certificate does not constitute a certification recognised by the RNCP or the Specific Directory (RS): it attests to participation and the assessment of learning outcomes within the framework of a continuing professional training action.
Satisfaction and results
Satisfaction rate: Being measured
First learner survey campaign under way — data published once the statistical threshold is reached.
Training team
Training delivered by the ISOFAC ACADEMY teaching team, made up of consultants specialised in medical devices, quality and regulatory affairs. Depending on the module, the session is led by a specialist with hands-on operational expertise in MDR compliance, ISO 13485 quality management systems, ISO 14971 risk management, clinical evaluation, technical documentation, regulatory audits and CE marking strategy.
Our trainers support manufacturers, distributors, importers, authorised representatives and other economic operators on a daily basis in bringing their medical devices into compliance. See the team's profiles →
Technical resources
In-person
Room equipped at the client site or in a partner centre (Montpellier, Lyon, Paris). Video projector, flipchart, printed materials.
Remote
Zoom (corporate) platform for the virtual classroom. Materials provided in PDF + access to additional resources for 12 months after the session.
Learner equipment
A connected computer with camera and microphone for remote sessions. No software to install.
Materials provided
- ·Annotated slide deck
- ·Annotated extracts of ISO 14971:2019
- ·Blank FMEA worksheets and risk management tables
- ·File review checklist
Post-course follow-up
Advice line
Hotline included for 30 days after the session for operational questions arising back on the job. Reply within 48 working hours.
Follow-up review
3-month review sent to the sponsor for in-house courses: feedback on the skills put into practice and any residual points.
Open-enrolment price (excl. VAT)
1 490 €
EU VAT applicable depending on the buyer's status.
In-house price
On request, depending on headcount and location.
Funding
- ·This training is not Qualiopi certified and cannot be funded via the OPCO
- ·Funding from own funds or the company's training budget
Personalised quote within 48 hours.
Would you like to attend this course?
Tell us your preferred format (open-enrolment, in-house or virtual classroom), the number of participants and your schedule. We will get back to you within 48 hours with the next available dates and a firm quote.