MD Software in Agile Methodology — Adapting IEC 62304 to Iterative Development Modes
Agile teams in the medical device sector face an operational paradox: iterative methods accelerate product delivery but clash with the traceability, classification and risk management requirements imposed by IEC 62304 and the MDR 2017/745 regulation. This one-day training gives developers, Scrum Masters and QA managers the concrete tools to design a fully compliant Agile process, without sacrificing agility on the altar of documentation.
Audience MD software developers, Scrum Masters, Product Owners, QA engineers and software quality assurance managers working in iterative development environments.
Learning objectives
- ▸ Identify the IEC 62304 requirements applicable to each stage of the software life cycle and articulate them with the corresponding Scrum events
- ▸ Classify software components (classes A, B, C) in the context of a sprint and derive the required level of documentation
- ▸ Integrate software risk management according to ISO 14971 into Agile rituals (backlog refinement, sprint planning, retrospective)
- ▸ Build a regulatory Definition of Done compatible with IEC 62304 for user stories covering safety functions
- ▸ Produce the documentary artifacts expected in the technical file (software requirements, test plan, verification report) following a continuous documentation logic
- ▸ Distinguish activities relating to software validation within the meaning of ISO 13485 from those relating to verification within the meaning of IEC 62304, and allocate responsibilities within the team
Expected outcomes
- ✓ At the end of the training, the participant is able to adapt the Scrum framework to their regulatory context without starting from scratch, draft the IEC 62304 deliverables on an ongoing basis rather than during a final consolidation phase, and demonstrate to an auditor the consistency between development iterations and control of the software life cycle.
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
Routine practice of a software development method (Scrum, Kanban or equivalent). General knowledge of the MD regulatory environment is an asset but is not required. No formal prerequisite on IEC 62304.
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 OPCOs
- ·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 of MD software (1 h)
- ·MDR 2017/745 regulation and the place of software (SaMD, embedded software, classification according to rule 11 and Annex VIII)
- ·Position of IEC 62304 as a harmonized standard
- ·Articulation with ISO 13485, ISO 14971 and IEC 62366
- 02
IEC 62304: key requirements and software classification (1 h 30)
- ·Development process (§ 5), maintenance (§ 6), problem management (§ 9)
- ·A / B / C classification and documentary implications
- ·Identification of SOUP (Software of Unknown Provenance) in an Agile environment
- 03
Mapping Scrum to IEC 62304: the operational model (2 h)
- ·Correspondence between Scrum artifacts and IEC 62304 deliverables: Product Backlog / software requirements, Sprint Backlog / detailed design, increment / unit verification
- ·Regulatory Definition of Done: how to build and validate it
- ·Managing user story / requirement / test traceability in an iterative environment
- ·Practical exercise: drafting a compliant DoD for a class B feature
- 04
Integrating ISO 14971 into Agile rituals (1 h 30)
- ·Continuous vs. one-off software risk analysis: advantages and conditions of viability
- ·Updating the Risk File over the course of the sprints
- ·Link between criticality of residual risks and acceptance criteria in the Definition of Done
- 05
Continuous documentation and technical file (45 min)
- ·Ongoing documentation strategy: when to produce what
- ·Design review in Agile mode: how to satisfy § 5.3 without deviating from velocity
- ·Preparation of deliverables for audit or notified body
- 06
Synthesis workshop and Q&A (15 min)
- ·Feedback on the situations brought by the participants
- ·Identification of the points of vigilance specific to each company context
Assessment of learning
Assessment methods
Quiz of 15 questions at the end of the day covering software classification, Scrum / IEC 62304 correspondence and documentary obligations. A practical role-play exercise (building a regulatory Definition of Done) is carried out during the session and gives rise to individualized trainer feedback.
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 by the RNCP or 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
- ·Annotated slides in PDF format
- ·Ready-to-use Scrum / IEC 62304 mapping grid
- ·Regulatory Definition of Done template
- ·Annotated normative bibliography
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 cannot be funded via the OPCOs
- ·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.