Compliance in Innovation

Regulatory standards are integrated early to avoid delays and ensure smooth approval processes

About Us

Our go-to-market offer

Free Regulatory Advice

- Submission Management

- FDA Correspondence

- Document Compilation

- Document Creation

Start from €149/month

Our Expert

Our Team

AX1 GmbH (pronounced "Action") calls for the democratization of the medical device industry! The team of renegade industry veterans from Switzerland & Germany is ready to bring a new era of market access and alleviate the regulatory burden. We are fun, passionate in collaboration and always deliver high-quality work.

Daniel Wehrwein

Senior Project Manager

Built on engineerig background within the last 15 years, Daniel gathered extensive experience in the MedTech an IVD industry as an experienced project leader in RnD, RA and Quality. Daniel specializes on leading project in the development and industrialization.

Mail