Medical Device Regulation: Your technical documentation determines whether you receive authorization

The Medical Device Regulation provides strict requirements for technical documentation. In the event of non-compliance, there is a risk that the notified agency will refuse certification.

File Formats for Translation: How to Send Us the Right One

Did you need the translation yesterday? If you send us these file formats, you will speed up the process enormously.

ISO 9001 - A standard you can rely on

ISO 18587 - MT is on the way

ISO 17100 - MDR & IVDR are on the way

CAT tools

Central Procedures (CP)

Corporate language

Corpus

Decentralized Procedures (DCP)