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Service

Our Service

Our expertise eliminates delays, simplifies compliance, and relieves resources so you can focus on growth.

Project Management

Requirements Engineering

Capturing, analyzing, documenting requirements of your medical device

- User Need Documents

- Risk Management Files (FMEA)

- Set of Requirements

Project Management

Verification and Validation

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

- Test cases creation

- Test automation

- Test execution and documentation

Project Management

Project Management for Certification

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

Project Management according to the V model

- Certification Body Reports (CB)

- MDR / FDA Registration

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

Who we are

We carry extensive experience from unique projects within Medtech

FAQ

  • Outsourcing is worthwhile for companies of all sizes that want to reduce their internal administrative workload.

    If you need more time for your core business and want to rely on reliable medical expertise. Fast-growing companies in particular benefit from outsourcing at an early stage.

  • Within 1 business week an initial meeting can be arranged.

    Within 2 weeks a consultant can start the work on your project

  • Our Unique Selling Point (USP) is our comprehensive understanding of both the technical and regulatory aspects of the medtech industry. We offer a unique blend of clinical expertise, regulatory knowledge, and market insights, enabling us to guide you through every stage of product development and commercialization. Our hands-on approach and customized strategies ensure that your products meet all necessary standards while also being positioned effectively in the market.

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Your Reliable Partner for your MedTech Project

Go-to-Market, Scale, and Stay Compliant with AX1

Swiss MedTech Project Management

Accomplish more together with AX1 Medical now!

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