Post-market support for medical devices

After a product has been placed on the market, medical devices must be monitored through systematic processes in accordance with MDR. Post-Market Surveillance (PMS) and Post-Market Clinical Follow-Up (PMCF) ensure that the product continues to meet requirements for safety, performance and clinical benefit.

We help you collect, analyse and interpret data from use in clinical settings, identify trends and document results in line with regulatory requirements. We can also support work related to incident reporting, corrective actions and regulatory follow-up.

When medical devices are used in real-world environments, new questions may arise regarding materials, function or use. Analysis and troubleshooting are therefore important parts of post-market work.

We offer laboratory analyses and technical expertise to identify the causes of deviations or production issues. This may include surface analysis, chemical problem solving, microbiological testing or material evaluation.

We can also support work involving measurement technology, calibration and quality assurance to ensure continued product performance.

During the post-market phase, large amounts of data are often generated from products, usage and digital services. Through structured data collection and analysis, this information can be used to identify risks, improve products and strengthen decision-making.

We help you analyse and visualise data from medical devices, digital services and sensors. Using data analysis and artificial intelligence, you can identify patterns, track product performance over time and make more informed decisions.

We also offer expertise in e-health, health data and user-centred analysis.

Digitalisation plays an increasingly important role in post-market activities. Connected medical devices and digital services continuously generate data that can be used for monitoring, improvement and regulatory documentation.

We help you develop structures for collecting, analysing and following up data from connected products — for example through IoT, sensors and digital platforms.

What is Post-Market Surveillance (PMS)?

PMS is the systematic monitoring of a medical device after it has been placed on the market. Under MDR, manufacturers must collect, analyse and document data on product safety and performance.

What does PMCF (Post-Market Clinical Follow-Up) mean?

PMCF is part of PMS and involves collecting clinical data after market launch to ensure continued safety and clinical benefit.

When is recertification of a medical device required?

If significant changes are made to the design, materials, software or intended purpose, a new assessment under MDR may be required. Updates to the technical documentation may also be necessary.

How should deviations and recalls be handled?

Manufacturers must have procedures in place for reporting serious incidents and implementing corrective actions (FSCA). This includes risk assessment, reporting to authorities and documentation.

How can data and AI be used in the post-market phase?

Collected product and user data can be analysed to identify trends, risks and opportunities for improvement. AI and data analytics can provide decision support for quality monitoring and product improvement.