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Your Partner
for your MedTech
Project

We understand each project as unique as each customer

Service

Our Service

Let's unlock the progress!

Requirements Engineering

Capturing, analyzing, documenting requirements of your medical device

- User Needs

- Risk Management

Engineering

Planning and organizing your Advanced project with our skill expertise

- Project Management

- Design History File (DHF)

Verification and Validation

Ensure that your medical device meets the requirements and needs of your users

- Evaluation

- Documentation

Project Management for Certification

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

- Certification Body (CB) Reports

- MDR / FDA Registration

Who we are

We carry extensive experience from unique projects within Medtech

Our Experts

01

Committed to advance life science in Germany, Austria and Switzerland (DACH)

We want to support SMEs in the DACH region to expand into the market while managing these processes efficiently. We believe safer products can bring an advancement of healthcare in Switzerland.

02

Experience in complex medical technology projects

We are built on experience from prototype to certification of 650 products in 135 countries. Our specialists offer tailored expertise and compliance services, particularly in CE and MDR

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Your Reliable Partner for your MedTech Project

For us, each project is treated the as uniquely as our clients themselves

Accomplish more together with AX1 Medical now!

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