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Requirements Engineering

Capturing, analyzing, documenting requirements of your medical device

We create and manage requirements
User Needs, Design Inputs, and other Requirements are fundamental when compiling your Design History File / Technical File.

About Us

Our Requirement Engineering Services

- User Need Documents

- Risk Management Files (FMEA)

- Set of Requirements

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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