Technical documentation

Our consultants provide technical documentation support throughout the entire lifecycle of your medical device – spanning pre- and post-marketing authorization.

In the pre-marketing authorization phase, our regulatory experts will perform thorough gap analyses as part of your regulatory strategy – identifying needed documentation to complete your premarket submission.

After receiving FDA authorization, or being granted CE mark, Eurofins Medical Device Consulting maintains applicable technical documentation for your device. Managed documentation may include, but is not limited to, change assessment documentation updates, technical file, and design history file maintenance, as well as communication with authorized representatives and competent authorities (e.g. FDA).