Design and development process under ISO 13485 — Architecture and documentation control
From the design plan to the production transfer file, this training gives R&D and quality teams the keys to structure, document and audit the design control process in compliance with the requirements of ISO 13485:2016 and MDR 2017/745. Zero superfluous theory: each session is grounded in concrete documentary cases from the medical device sector.
Audience R&D engineers, project managers, quality managers, and anyone involved in the design or documentary review of medical devices within the meaning of § 7.3 ISO 13485.
Learning objectives
- ▸ Identify the applicable requirements of § 7.3 ISO 13485 (§ 7.3.1 to § 7.3.10) and their connections with the General Safety and Performance Requirements (GSPR) of Annex I of MDR 2017/745
- ▸ Build a compliant design and development plan, defining the required stages, responsibilities, reviews and documentary milestones
- ▸ Draft or revise the key design control documents: design inputs (§ 7.3.3), design outputs (§ 7.3.4), design review records (§ 7.3.5), verification (§ 7.3.6) and validation (§ 7.3.7) protocols
- ▸ Apply the requirements for control of design changes (§ 7.3.9) by distinguishing minor changes from significant changes within the meaning of the MDR
- ▸ Compile the design file (Design History File / § 7.3.10) consistently with the MDR technical documentation (Annex II)
- ▸ Assess the compliance of an existing design file against a normative verification checklist
Expected outcomes
- ✓ Participants leave with a self-assessment checklist for their own design control process and the document templates covered in the workshop.
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 ISO 13485:2016 recommended. Experience in an R&D or medical device quality environment is an asset. No formal blocking prerequisites.
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 through 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
Normative and regulatory framework of design control (1 h 30)
- ·Cross-reading of § 7.3 ISO 13485 and the GSPR of Annex I of the MDR
- ·Identification of permitted exclusions and their documentary conditions
- ·Links with ISO 14971 (risk management) in the design phase
- 02
Design and development planning (§ 7.3.1 and § 7.3.2) (1 h 30)
- ·Structure of a design plan: stages, responsibilities, organizational interfaces, management of transfers between teams
- ·Workshop: critical analysis of an existing design plan
- 03
Design inputs and outputs (§ 7.3.3 and § 7.3.4) (2 h)
- ·Traceability between user needs, functional specifications and design specifications
- ·Requirements for completeness, approval and recording
- ·Workshop: drafting a traceability matrix on a running case study
- 04
Design reviews, verification and validation (§ 7.3.5, § 7.3.6, § 7.3.7) (2 h 30)
- ·Acceptance criteria and protocols
- ·Distinction between verification (compliant with specifications) and validation (fit for intended use)
- ·Management of deviations and nonconforming results
- ·Workshop: building a simplified validation protocol
- 05
Transfer to production and design file (§ 7.3.8 and § 7.3.10) (2 h)
- ·Transfer requirements (§ 7.3.8): verification of transposability under manufacturing conditions
- ·Compilation and maintenance of the design file (Design History File)
- ·Connection with the MDR technical documentation (Annex II)
- ·Workshop: review of a partial design file
- 06
Control of design changes (§ 7.3.9) (1 h 30)
- ·Change control process applied to design: assessment of the regulatory impact
- ·Classification of changes (minor / significant within the meaning of the MDR), notification to the notified body
- ·Case studies
- 07
Overall assessment and maturity grid (1 h)
- ·Self-assessment of your organization's design control process
- ·Points of vigilance in an ISO 13485 audit
- ·Discussions and Q&A
Assessment of learning
Assessment methods
20-question QCM at the end of the training (§ 7.3 and its associated documentary requirements), supplemented by a practical exercise: participants submit a page of a design file containing intentional gaps for correction.
Certificate
Training certificate issued by ISOFAC Group at the end of the training, subject to full attendance over the two days. This certificate does not constitute a certification recognized under the RNCP or the Répertoire Spécifique (RS); it attests to participation and to the assessment of acquired knowledge within the framework of continuing professional 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
- ·Course materials in PDF format
- ·Annotated normative excerpts: § 7.3 ISO 13485, Annexes I and II of the MDR
- ·Design control document templates: design plan, traceability matrix, validation protocol, change form
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 through 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.