Technical documentation – the core of your medical device

Does any of these scenarios sound familiar? You’ve just received a list of nonconformities from your Notified Body or the FDA, and you’re not sure what they’re talking about or what you should do next? Or is your technical documentation a complete mess, or does it simply need to be updated 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.

From the Field: Projects That Make a Difference

How we help pharmaceutical, medtech, and healthcare companies safely bring digital medical devices to market.

InfectoPharm

Meine Tinnitus App
Migration and further development of a certified DiGA
Here’s how we did it: Meine Tinnitus App

Cimon Medical

NeoDoppler
Hardware and software engineering through to MDR certification
Here’s how we did it: NeoDoppler

Behind each of these stories was an initial conversation. Write your success story with us and tell us what you’re currently working on.

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

Because we know what matters most when creating technical documentation. Our teams have already supported over 30 medical software and app projects and guided clients through various conformity assessment procedures and FDA approvals. And with this very expertise, we’d love to help you and your technical documentation for your medical device move forward.