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Service

Our Service

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

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Compliance in Innovation

Fast track to enter the market

- Determine classification and intended use

- Compiling technical documentation

- Issue declaration of conformity

- Submission of documentation

- Correspondence with Notified Body / FDA

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Compliance in Operation

Fast track to enter the market

- Compliance Monitoring

- License Management

- Regulatory advice

- Recertification

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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 DACH and European market.

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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Integrate Compliance into Innovation & Operations

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

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Accomplish more together with AX1 Medical now!

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