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Our process

AX1 Medical supports original equipment manufacturers (OEMs) and companies throughout the entire process of bringing medical devices to market, from concept to market readiness. First, we ask about the intended use of the medical device. In addition, we assess safety, efficacy and regulatory compliance.

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Consultation

With a deep understanding of the intended use of the medical device, we assess its safety, effectiveness, and compliance with regulations.

Planning

Creating a comprehensive strategy for obtaining certification, such as identifying applicable standards and regulations, defining the certification scope, establishing timelines and milestones, assigning responsibilities, and allocating resources efficiently.

Documentation

All our services come with detailed documentation to ensure a seamless and high-quality process.

Execution

The execution phase involves implementing the planned activities of testing, audits, clinical evaluation, and potentially preparing the certification submission.

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