Clinical Evaluations
According to the MEDDEV 2.7/1 rev. 4 directive, in English, optionally in German.
MDR
The transitional period of the new Medical Devices Regulation will end soon. Have all precautions been taken?
Post-Market Surveillance (PMS)
The post-market surveillance - an integral part of the
quality management.
Post-Market Clinical Follow-up (PMCF)
Post-Market Clinical Follow-up is an ongoing process to assess the safety and performance of a medical device.
Biological Evaluations
To assess the biological safety of medical devices, manufacturers need today to identify and evaluate potential risks.
Preparation and Maintenance Technical Documentation
Take the opportunity to critically review and carefully revise the file at an early stage.
CE Certification of medical devices
We support you in the preparation or revision of key documents for CE Certification.