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Post market surveillance

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. MDD or MDR).

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

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With the introduction of the new MEDDEV 2.7/1 rev. 4 in 2016 and the publication of the MDR in 2017 the focus on clinical evidence supporting your products has significantly increased. As a result of this trend PMCF plans and programs have become a significant factor of your clinical activities. Our medical affairs experts are particularly qualified and experienced ensuring the proper settlement of all PMS obligations. 

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