Managing an innovative medical-device project — Project management in the MDR regulatory environment
Bringing a medical device to the European market is a complex operation that simultaneously mobilises project-management, engineering, quality and regulatory-affairs skills. This training gives project managers, R&D engineers and management the tools to structure, plan and steer a medical-device project by integrating the constraints of Regulation (EU) 2017/745 from the scoping phase onward, rather than as a constraint endured at the end of the cycle.
Audience Project managers, R&D engineers, product marketing managers, executive management and any manager involved in leading or supervising a development, market-launch or CE-marking renewal project for a medical device.
Learning objectives
- ▸ Identify the mandatory MDR regulatory milestones (classification, designation of the notified body, GSPR, technical file, EUDAMED) and integrate them into the project schedule from the scoping phase onward
- ▸ Build a work breakdown structure (WBS) adapted to the constraints of a medical-device life cycle, including the design and development processes according to ISO 13485 §7.3
- ▸ Analyse project risks of a regulatory nature (change of classification, evolution of the clinical surveillance plan, notified-body delays) and define the corresponding mitigation actions
- ▸ Coordinate the internal and external stakeholders of a medical-device project (R&D, quality, regulatory affairs, manufacturing, notified body) by defining clear responsibilities via a RACI matrix
- ▸ Apply progress-control methods and change management during the project while complying with ISO 13485 traceability requirements
- ▸ Prepare and present a project-review report to management, integrating regulatory-compliance indicators
Expected outcomes
- ✓ Have an operational method for steering a medical-device project in a constrained regulatory environment
- ✓ Anticipate regulatory bottlenecks and organise multidisciplinary resources
- ✓ Produce project deliverables compatible with MDR technical-documentation requirements
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
Professional experience in the medical-device industry (R&D, quality, regulatory affairs, project management). No project-management certification required. A basic knowledge of MDR Regulation 2017/745 is recommended (the IA-REG-02 training provides suitable preparation).
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
The MDR regulatory environment as a structuring framework for the project (3 h)
- ·MDR 2017/745 requirements applicable to the development cycle: device classification, role of the notified body, mandatory technical-documentation milestones
- ·Linkage between project management and ISO 13485 §7.3 processes (design and development)
- ·Mapping of regulatory deliverables by project phase
- 02
Structuring and planning a medical-device project (3 h)
- ·Definition of the project scope and objectives
- ·Building the WBS adapted to medical-device constraints
- ·Planning the phases and review milestones (design review)
- ·Identification and allocation of multidisciplinary resources
- ·RACI matrix applied to multi-actor projects (R&D, QA, RA, notified body, critical suppliers)
- 03
Managing project risks in a regulatory environment (3 h)
- ·Risk typologies specific to medical-device projects: technical, clinical, regulatory (evolution of classification, NB delays, additional requests), industrial
- ·Method for analysing and prioritising project risks
- ·Integration of the project risk register into the steering system
- ·Linkage with product risk management (ISO 14971)
- 04
Steering, communicating and closing the project (3 h)
- ·Monitoring indicators and project dashboard
- ·Management of changes during the project and traceability of decisions
- ·Communication to management: preparation of a project-review report integrating regulatory indicators
- ·Project closure and capitalisation of lessons learned
- ·Review and assessment of learning outcomes
Assessment of learning
Assessment methods
A 20-question QCM at the end of the training covering modules 1 to 4 and a practical exercise based on a running case study on steering a medical-device project. Results are communicated individually at the end of the training.
Certificate
Training certificate issued by Isofac Group at the end of the training, subject to full attendance over the two days. This certificate attests to participation and to the assessment of learning outcomes within the framework of continuing professional training; it does not constitute a certification recognised by the RNCP or by the Répertoire Spécifique (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.
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 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.