Contact person
Sara Bogren
Avdelningschef
Contact SaraPost-market support for medical devices
Medical devices must be monitored even after they have been launched on the market. Regulations such as the MDR impose increased requirements for systematic post-market monitoring, data collection and clinical follow-up through Post Market Clinical Follow Up (PMCF) och Post Market Surveillance (PMS). At the same time, manufacturers must manage deviations, product changes and regulatory updates. Explore how we can support your post-market activities.
IDEA & CONCEPT | PRODUCT DEVELOPMENT | POST MARKET
We help you work in a structured way with follow-up, analysis and documentation — from handling deviations and product changes to data-driven monitoring throughout the product lifecycle.
Post-market support for medical devices
Troubleshooting and improvements
We support manufacturers with troubleshooting. We can assist with the analysis of production deviations (for example, cleaning issues or material variations) or clinical samples:
- Analysis of materials and surfaces with imaging mass spectrometry | RISE
- Imaging of biological surfaces and medical devices with SEM | RISE
- Microscopy analysis of biological surfaces | RISE
- Chemical problem solving
- Microbiological analysis methods
We also perform calibrations and testing and contribute with metrology expertise in assignments and research projects: The National Laboratory for Volume and Flow | RISE
Data analysis and AI
We help answer common questions related to data collection and analysis for existing products. For example, can AI be used to improve analysis and insights?
Examples of RISE expertise in e-health and healthtech include:
We also have expertise in developing reliable decision support based on health and social value as well as user experience (UX/usability).
Digitalisation and connected medical devices
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.
FAQ
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.
Get in touch
Are you working with a medical device that is already on the market and need support in the post-market phase? We help you navigate requirements related to PMS, PMCF, analysis and regulatory follow-up under MDR. Contact me to discuss how we can support your post-market activities.
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