FMEA applied to quality risk control in medical devices — The quality AND regulatory tool that your QMS must be able to defend
FMEA, a quality tool or a regulatory tool? Both — and your QMS must prove it. In one day, move from theory to an operational worksheet: build or strengthen your FMEA analyses in strict compliance with ISO 13485 and MDR 2017/745 requirements, with concrete cases drawn from the medical-device field.
Audience Quality managers and engineers, regulatory affairs officers, R&D engineers involved in risk management within medical-device manufacturing or subcontracting organizations.
Learning objectives
- ▸ Distinguish the different types of FMEA (product, process, system) and identify their scope of application within an ISO 13485-certified QMS.
- ▸ Build an FMEA rating scale adapted to the requirements of MDR 2017/745 and consistent with the risk management file according to ISO 14971.
- ▸ Assess the criticality of failure modes (occurrence, severity, detectability) by integrating the patient dimension and the benefit/risk concept specific to the medical-device sector.
- ▸ Draft prioritized and traceable corrective and preventive actions (CAPA) based on the results of a process FMEA.
- ▸ Position FMEA within the quality process mapping and justify its use during a certification audit or regulatory inspection.
- ▸ Lead or co-lead a multidisciplinary FMEA session by applying facilitation rules adapted to the medical-device industrial context.
Expected outcomes
- ✓ Operational FMEA worksheet directly usable in the company.
- ✓ Associated action plan template (prioritization, responsibilities, deadlines, traceability).
- ✓ Immediate ability to initiate or revise an FMEA within one's organization.
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
Basic knowledge of quality management principles (ISO 9001 or ISO 13485). Prior exposure to the concept of risk in medical devices is recommended but not mandatory.
Disability access
Any disability situation can be accommodated. Contact our officer before registration to explore possible adjustments (equipment, materials, pacing). Contact our officer →
Funding
- ·OPCO (all sectors)
- ·Skills development plan
- ·CPF (subject to the course being listed)
- ·Company self-funding
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
Fundamentals of FMEA in the medical-device context (1h30)
- ·Definitions and typologies: product, process, system FMEA
- ·Regulatory positioning: link with ISO 14971, MDR 2017/745 and ISO 13485 requirements (§6.1, §7.3, §8.5)
- ·When and why to trigger an FMEA in a medical-device QMS
- ·Sector-specific medical-device examples (plastics, implantable devices, primary packaging)
- 02
Building the FMEA worksheet (1h30)
- ·Identification of failure modes and their effects
- ·Definition of rating criteria: occurrence, severity (patient/user severity), detectability
- ·Adapting the scales to the medical-device framework: integrating the concept of acceptable residual harm
- ·Applied exercise: rating on a running case study — class IIa medical device suggested
- 03
Criticality calculation and prioritization of actions (1h)
- ·Risk Priority Number (RPN): calculation, interpretation, limitations
- ·Prioritization of critical failures
- ·Transition to the CAPA action plan: drafting criteria, responsibilities, deadlines, documentary traceability
- 04
Hands-on practice: process FMEA workshop (2h)
- ·Work in subgroups on a provided medical-device file
- ·Guided facilitation of a complete process FMEA (identification, rating, actions)
- ·Presentation and critical inter-group review
- ·Trainer's synthesis on the most frequent deviations in medical-device process FMEA
- 05
Integration into the QMS and audit preparation (1h)
- ·Positioning of the FMEA within the quality documentation (process mapping, risk management file)
- ·Review of what an ISO 13485 auditor or notified body expects on this point
- ·Recurring errors observed during audits: rating scale inconsistent with ISO 14971, orphan FMEA, lack of periodic review
- ·Questions and answers and synthesis
Assessment of learning
Assessment methods
Final 15-question QCM (modules 1 to 3, passing threshold: 70%) · Self-assessment grid of competencies acquired in the workshop (module 4) qualitatively assessed by the trainer · Training certificate issued by ISOFACADEMY subject to full participation in the entire day. This certificate does not constitute an RNCP/RS certification; it attests to participation and to the assessment of learning outcomes within the framework of a continuing professional training action.
Certificate
A certificate of completion is issued to each participant, detailing the objectives, duration, learning assessed and the result of the final assessment. The document can be kept in a skills record.
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.
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)
790 €
EU VAT applicable depending on the buyer's status.
In-house price
On request, depending on headcount and location.
Funding
- ·OPCO (all sectors)
- ·Skills development plan
- ·CPF (subject to the course being listed)
- ·Company self-funding
Personalised quote and OPCO funding application prepared 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.