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Post market surveillance for devices

Post-market surveillance (PMS) - the clinical maintenance program for the bridge. Once your device has obtained its CE mark Post Market Surveillance (PMS) is a requirement. Post Market Clinical Follow-up (PMCF) is part of the PMS obligations and there are various PMCF scenarios possible - we can help you selecting the most appropriate one for your products. Whether it's a small follow-up programme or a complete PMCF study, we know how to plan, execute and report the results so that you are fully compliant with applicable regulatory requirements (e.g. MDR/ IVDR).

PMS also has the potential to reinforce your products! Contact us for the "Lacidem PMS health check" and find out if you are compliant and optimally benefiting from your PMS activities.

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The new regulatory landscape brings along an increased focus on clinical activities supporting medical devices. PMCF plans and programs may become a significant factor of your clinical activities.

Lacidem medical affairs experts are qualified, experienced and skilled ensuring the appropriate development and conduct of your PMS and PMCF obligations.

Lacidem
Wilhelminalaan 6
3761 DN Soest

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