Medical Device Software — Mastering the Life Cycle and IEC 62304 Compliance
Is your software a medical device in its own right, an embedded component, or health software (SaMD)? The answer determines your entire development cycle, your technical documentation and your CE marking. The IEC 62304 standard defines the mandatory regulatory framework for any manufacturer subject to MDR 2017/745. This one-day training course, designed for technical and quality teams, translates the normative requirements into concrete practices for development, risk management and documentation.
Audience Software developers, software architects, software quality engineers (QA), R&D project managers, regulatory affairs managers involved in MD software projects.
Learning objectives
- ▸ Identify the scope of the IEC 62304 standard and qualify the regulatory status of the software (embedded software, SaMD, SOUP) with regard to MDR 2017/745
- ▸ Classify software according to the three IEC 62304 safety classes (A, B, C) by applying the criticality analysis methodology
- ▸ Structure a software development plan compliant with the life cycle processes defined by the standard (development, verification, validation, configuration management, maintenance)
- ▸ Articulate IEC 62304 requirements with the ISO 14971 risk management process and the MDR technical documentation requirements (Annex II)
- ▸ Identify the mandatory documentation to be produced for software requirements, architectural design, testing and traceability
- ▸ Apply IEC 62304 requirements in an iterative development context, including the management of SOUP and legacy components
Expected outcomes
- ✓ At the end of the session, participants have an operational reading framework to audit or build their software life cycle plan, identify documentation gaps and meet the requirements of notified bodies during the review of the technical documentation.
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
No formal prerequisites. Familiarity with the basics of software development (V-model, testing or architecture concepts) and exposure to the MD regulatory context facilitate the assimilation of the content, without being 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
- ·This training is not Qualiopi-certified and is not fundable 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
Regulatory and normative framework for medical software (1 h)
- ·Definition and qualification of software according to MDR 2017/745: embedded software, SaMD, mobile application
- ·Articulation of IEC 62304 with IEC 62366-1 (usability), IEC 82304-1 (health software), ISO 13485 and ISO 14971
- ·Recognition by the FDA (recognized standard)
- 02
Software safety classification (1 h)
- ·Methodology for determining classes A, B, C
- ·Impact of classification on the scope of documentation obligations and verification processes
- ·Management of segregation between software items of different classes
- ·Practical classification cases
- 03
IEC 62304 software development process (2 h)
- ·Software requirements: specification and traceability
- ·Architectural design and detailed design
- ·Implementation and coding
- ·Design verification and testing
- ·Information provided to the user
- ·Design validation
- ·Management of SOUP (Software of Unknown Provenance) and legacy software
- 04
Software risk management and ISO 14971 articulation (1 h)
- ·Identification of software contributing causes to hazards
- ·Software-related risk control measures
- ·Integration of risk management outputs into software requirements and testing
- 05
Maintenance, configuration management and problem resolution (1 h)
- ·Software maintenance plan
- ·Change management and impact analysis
- ·Configuration management: versioning, identification of software items
- ·Problem resolution process
- 06
Documentation and technical documentation — what the notified body expects (1 h)
- ·List of documentation deliverables by class
- ·Consistency check with MDR Annex II
- ·Verification and validation evidence expected during the certification audit
Assessment of learning
Assessment methods
QCM to validate the knowledge acquired at the end of the day, covering the key concepts addressed in the six modules (classification, life cycle processes, documentation, software risk management). The results are communicated to the participant at the end of the assessment.
Certificate
Training certificate issued by Isofac Group at the end of the training, subject to full participation in the session. This certificate does not constitute a certification recognized by the RNCP or the Specific Directory (RS). It attests to participation in and completion of the training.
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 and summary sheets per module
- ·Commented normative excerpts
- ·Practical classification cases
- ·Annotated software development plan template
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)
890 €
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 fundable 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.