Support compliant post-market follow-up activities for medical devices and software through structured monitoring, documentation, and regulatory oversight processes.
Post-market follow-up planning
PMS and PMPF process support
PMCF and performance follow-up support
Trend reporting and data analysis
Vigilance and incident management support
Post-market documentation reviews
Feedback and complaint process alignment
Ongoing regulatory compliance support
Post-market follow-up is a continuous regulatory requirement under MDR and IVDR. Manufacturers are expected to actively monitor device performance, review post-market information, assess risks, and maintain documentation throughout the product lifecycle.
MedQAIR supports organisations in establishing and maintaining post-market follow-up processes aligned with MDR, IVDR, FDA guidance, and related international frameworks. This includes PMS and PMPF planning, PMCF support, vigilance activities, trend analysis, and post-market documentation management.
Our approach focuses on practical implementation across quality, regulatory, and operational activities. Effective post-market follow-up supports ongoing compliance while helping organisations identify issues early, maintain product oversight, and support long-term device safety and performance.
Support with establishing post-market surveillance and post-market performance follow-up activities aligned with applicable regulatory requirements.
Support for post-market clinical follow-up planning, data collection, evaluation, and associated documentation activities.
Support with incident handling, vigilance processes, reporting workflows, and associated regulatory obligations.
Support for identifying trends, reviewing post-market information, and maintaining ongoing oversight of product performance and safety.
Review and support for post-market reports, documentation updates, and alignment with technical and quality system requirements.
Support with maintaining post-market processes, audits, inspections, and evolving regulatory expectations throughout the device lifecycle.
Find answers to common questions about our services, compliance processes, and how we can assist your business.
Post-market follow-up refers to the ongoing activities manufacturers perform after a device is placed on the market to monitor safety, performance, risks, complaints, and regulatory compliance throughout the product lifecycle.
PMS (Post-Market Surveillance) covers the broader monitoring of device performance and safety after market release. PMPF (Post-Market Performance Follow-Up) applies primarily to IVDs, while PMCF (Post-Market Clinical Follow-Up) relates to gathering ongoing clinical data for medical devices under MDR.
Software and AI-enabled systems continue evolving after release through updates, integrations, cybersecurity changes, and real-world use. Post-market follow-up helps manufacturers monitor performance, identify emerging risks, and maintain regulatory compliance over time.
(Existing FAQ from MedQAIR FAQ page — relevant to this service page)
Post-market compliance is a significant part of our work. We support EUDAMED registration, post-market surveillance, vigilance reporting, audits, regulatory due diligence, and interim PRRC and DPO roles.
A PMS system should define how post-market information is collected, analysed, reviewed, and acted upon throughout the product lifecycle. This may include complaints, incidents, trend data, customer feedback, corrective actions, literature reviews, and other information relevant to device safety and performance.
PMCF is required when ongoing clinical evidence is needed to confirm the safety, performance, and benefit-risk profile of a medical device after market placement. Under MDR, PMCF forms part of the broader post-market surveillance system and should be proportionate to the device’s risk class and clinical uncertainties.
Trend reporting involves monitoring post-market data to identify statistically significant increases in incidents, complaints, or undesirable events. Early identification of trends can help manufacturers investigate potential issues before they develop into broader safety or compliance concerns.
Post-market surveillance is the broader process of monitoring device performance and safety after release. Vigilance activities focus specifically on reportable incidents, serious incidents, field safety corrective actions, and communications with competent authorities regarding safety-related events.
Review frequency depends on device classification, risk profile, regulatory requirements, and emerging post-market information. Manufacturers should establish documented procedures that ensure reports, risk assessments, trend analyses, and supporting records remain current throughout the product lifecycle.
Post-market activities provide real-world information that can confirm or challenge assumptions made during development and clinical evaluation. This information should feed back into risk management processes to ensure hazards, benefits, and mitigation measures remain appropriately assessed.
Yes. Post-market findings may result in updates to technical documentation, labelling, risk management files, clinical evidence, software updates, field safety corrective actions, or regulatory submissions when changes are necessary to maintain safety, performance, or compliance.
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