Post-Market Surveillance — Structuring your PMS system and managing field signals
Regulation (EU) 2017/745 makes post-market surveillance (PMS) a structuring obligation, not an end-of-file formality. Multiple data sources, interactions with vigilance, production of PSUR or PMSR reports depending on the device class: RA and QA teams must master both the architecture of the PMS system and the operational management of field signals. This one-day training gives you the tools to build or consolidate your PMS system, qualify and prioritize signals from the field, and produce the regulatory documentation expected by competent authorities and notified bodies.
Audience Regulatory affairs (RA) managers and officers, quality managers (QA), vigilance managers, persons responsible for regulatory compliance (PRRC), engineers or product managers involved in the post-market phase.
Learning objectives
- ▸ Identify the requirements of MDR 2017/745 (Chapter VII, Articles 83 to 92) and how they articulate with ISO 13485 §8.2 regarding post-market surveillance
- ▸ Build the documentary architecture of a compliant PMS system: surveillance plan (PMSP), data collection and analysis procedure, interactions with risk management and clinical evaluation
- ▸ Distinguish the types of reports expected (PMSR for class I / low-risk IIa devices, PSUR for class IIa, IIb and III devices) and draft their structuring elements
- ▸ Qualify and prioritize field signals: customer complaints, product returns, reported incidents, literature alerts, competitor data, healthcare professional feedback
- ▸ Analyze the interactions between the PMS system and related processes: vigilance, CAPA, PMCF (Post-Market Clinical Follow-up), management review
- ▸ Set up an operationally usable dashboard for monitoring PMS indicators
Expected outcomes
- ✓ A functional mapping of their PMS system
- ✓ An annotated PMSP template
- ✓ A field signal qualification grid directly adaptable to their product context
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 MDR 2017/745 recommended. Experience in quality or regulatory affairs in the medical device sector is an asset. 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 fundable 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
The regulatory framework of PMS under MDR (1 h)
- ·Chapter VII of the MDR: obligations of manufacturers, importers and distributors
- ·MDR / ISO 13485 §8.2 articulation
- ·Role of the PRRC in steering the PMS system
- ·Positioning of PMS in the device life cycle
- 02
Architecture of a compliant PMS system (1 h 30)
- ·Components of the system: surveillance plan (PMSP), data collection, analysis and processing procedures
- ·Proactive and reactive data sources
- ·Interactions with risk management (ISO 14971), clinical evaluation (CER) and PMCF
- ·Control points during an audit or an assessment by a notified body
- 03
Qualifying and managing field signals (2 h)
- ·Signal typologies: complaints, product returns, incidents and near-incidents, vigilance alerts, literature data, healthcare professional feedback
- ·Method for qualifying, prioritizing and escalating signals
- ·Link with CAPA triggering and trend reports (Article 88 MDR)
- ·Practical exercise: qualifying a batch of fictitious signals on a field case
- 04
PMS reports: PMSR and PSUR (1 h 30)
- ·Differences in scope and frequency depending on the device class (Articles 85 and 86 MDR)
- ·Expected structure and content of a PMSR (class I)
- ·Expected structure and content of a PSUR (class IIa, IIb, III): benefit/risk summary, trends, conclusions on performance
- ·Updating in connection with the SSCP and EUDAMED
- ·Exercise: guided completion of a PSUR skeleton
- 05
Dashboard and operational steering (1 h)
- ·Key performance indicators of the PMS system
- ·Building a monitoring dashboard
- ·Integration into the management review
- ·Presentation of the work and collective summary
Assessment of learning
Assessment methods
20-question QCM at the end of the day covering regulatory requirements, signal qualification and documentary structuring, supplemented by a short role-play: analysis of a fictitious field signal and production of a reasoned escalation decision.
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.
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 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.