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Project Management for Certification

Manage and coordinate your certification process to ensure compliance with the latest rules and standards

We plan and set up your medical device certification processes. AX1 Medical facilitates the generation and management of the Technical File including Design Control Management, Risk Management, V&V management as well as creating the Documents, reviews, approvals and signoffs.

About Us

Our Project Management for Certification Services

Project Management according to the V model

- Certification Body Reports (CB)

- MDR / FDA Registration

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.

Accomplish more together with AX1 Medical now!

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