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