Technical documentation – the core of your medical device

Do you recognize any of these scenarios? You have just received a list of deficiencies from your Notified Body or the FDA and don’t know what they are talking about and what you should do next? Or Is your technical documentation a mess or does it just need an update for the MDR or IVDR?

If you’re under pressure, you don’t need good advice. What you really need is someone who gets things done. And that’s exactly what our quality experts do. We are also happy to support you in preparing your technical documentation and files for software-based medical devices.

Why you don’t have to worry about the technical documentation?

Because we know what is important when creating technical documentation. Our teams have already supported over 30 medical software and app projects and accompanied various conformity assessment procedures and FDA approvals. And it is precisely this knowledge that we would like to use to help you and your technical documentation for your medical device move forward.