The maintenance of technical documentation according to the EU Medical Devices Regulation (MDR) is a necessary process to keep it up to date with regard to constantly changing regulatory requirements.
In the course of a year, legal or normative bases can change. BEO BERLIN publishes a monthly selection of new standards and standards projects (rev) that may be relevant for our clients.
We recommend conducting an annual research of standards and requirements for each product type.
BEO BERLIN checks at regular intervals determined in consultation with you whether and if so, what influence these changes have on your products. Our experts draw up a written assessment protocol and as a result you will receive a plan of action in which the points requiring adaptation or implementation are listed and explained.
Of course, we are also happy to support you in implementing the necessary measures.
Do you need help updating your CE documentation or would you like us to maintain it regularly?
