Product and process FMEA in a medical device environment
FMEA is the central tool for controlling design and manufacturing risks in the medical device industry. It feeds the Risk Management File required by ISO 14971, meets the expectations of notified bodies under MDR 2017/745, and determines the robustness of technical files submitted for audit. This intensive training gives R&D, quality, and methods teams the concrete tools to conduct or participate in a rigorous product FMEA and process FMEA study, in compliance with the sector's regulatory and normative standards.
Audience R&D engineers and technicians, methods and industrialization engineers, quality managers and coordinators, medical device design project managers, and anyone required to participate in or contribute to an FMEA study in a medical device environment.
Learning objectives
- ▸ Distinguish the respective purposes and scopes of product FMEA and process FMEA within a medical device's life cycle
- ▸ Link FMEA studies to the risk management requirements of ISO 14971:2019, IEC 60812 and to the requirements of MDR 2017/745 (Annex I — GSPR)
- ▸ Build or complete a product FMEA table by identifying functional failure modes, their effects and their causes, and by calculating a criticality index (RPN)
- ▸ Carry out a process FMEA on a medical device manufacturing process: map the elementary operations, identify the failures generated on the product, and define the associated control actions
- ▸ Prioritize corrective and preventive actions according to the level of residual criticality and integrate them into the Risk Management File
- ▸ Communicate the results of an FMEA study to a project team or an auditor using the appropriate normative terminology
Expected outcomes
- ✓ At the end of the training, the participant can conduct or co-facilitate a product or process FMEA session in their organization, feed their company's Risk Management File, and present the results with the level of rigor expected during an ISO 13485 audit or an MDR assessment.
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 medical devices and their regulatory environment recommended. Prior familiarity with the concepts of ISO 13485 QMS or ISO 14971 risk management is an asset, but not required. No formal blocking prerequisite.
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 is not eligible for OPCO funding
- ·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
Normative and regulatory framework of FMEA in medical devices (1 h)
- ·Positioning of FMEA within ISO 14971:2019 risk management and the ISO/TR 24971 guide
- ·Links with IEC 60812, ISO 13485 (§ 7.3, § 8.5) and the GSPR requirements of Annex I of the MDR
- ·Differences between product FMEA (design) and process FMEA (manufacturing): scopes, deliverables, responsibilities
- 02
Product FMEA: method and implementation (2 h)
- ·Structure of the product FMEA table and functional analysis as the basis of the study
- ·Functional and reliability failure modes; identification of effects (user, patient, product) and causes (design, materials, interfaces)
- ·Severity / Occurrence / Detectability rating and RPN calculation; acceptable criticality thresholds in a medical device environment
- ·Practical exercise on a simplified medical device case
- 03
Process FMEA: method and implementation (2 h)
- ·Structural differences with the product FMEA; mapping of the elementary operations of a medical device manufacturing process
- ·Identification of the failures generated on the product at each step; process causes (machine, environment, method, manpower, material)
- ·Rating and criticality calculation; link with the monitoring plan and process qualifications
- ·Practical exercise on a medical device process case
- 04
Action management and integration into the Risk Management File (1 h)
- ·Prioritization and corrective and preventive action plan; reassessment of residual criticality after actions
- ·Integration of the results into the Risk Management File (ISO 14971 § 9)
- ·FMEA review during product/process changes and management of living FMEAs
- ·Best practices expected by notified bodies during MDR audits
- 05
Summary, questions and answers, and assessment (1 h)
- ·Review of the key points
- ·Discussion of specific cases brought by the participants
- ·QCM to validate the knowledge acquired
Assessment of learning
Assessment methods
QCM of 15 to 20 questions covering the key concepts (FMEA criteria, normative links, criticality calculation, integration into the Risk Management File), administered at the end of the day. Supplemented by a practical role-play carried out during the group exercises (modules 2 and 3).
Certificate
Training certificate issued by ISOFAC Group at the end of the training, subject to full participation in the day. This certificate does not constitute a certification recognized in the National Directory of Professional Certifications (RNCP) or in the Specific Directory (RS).
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
- ·Course materials in PDF format
- ·Examples of real product FMEA and process FMEA tables (anonymized)
- ·Reference documentation: extracts from ISO 14971:2019, IEC 60812, Isofac rating grids
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
- ·This training is not Qualiopi certified and is not eligible for OPCO funding
- ·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.