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About Us

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.

Our Team

Our Experts

We treat everyone with kindness, empathy, and consideration. By treating everyone with respect, we foster a positive work environment. 

Valiation

Our team members excel in the knowledge, skills, and behaviors required by their roles. They consistently deliver their best work, fostering a culture of collaboration and innovation.

Responsbility

Our team members execute tasks with meticulous attention to detail. We rely on accurate data and analytics to guide our choices. Precision ensures that we make informed decisions, minimizing bias.

Precision

Khaled Jbir

Project & Test Manager

5+ years System verification and validation engineer in medical technology 

2+ years Project management in medical technology​
(ISO 13485, IEC 60601-1)

Daniel Wehrwein

Senior Project Manager

8+ years technical project manager in medical technology

10+ years in R&D in medical technology 
(ISO 13485/ IEC 60601-1/etc.) 

Suman Bhunia

Business Strategy Advisor

Vivian Maretina

Innovation Manager

Daniel Gross

Sales and Operations

Oliver Langwald

IT Administration

We are part of

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.

Our Value

Our Vision

"...to accelerate growth in life science and healthcare by driving innovation and ensuring the highest standards of safety and efficacy for medical devices"

Our
Skills

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 ensuring the safety of the products while managing these processes efficiently. We believe safer products can bring an advancement of healthcare in Switzerland, Germany, and Austria.

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.

Khaled Jbir

Project & Test Manager

5+ years System verification and validation engineer in medical technology

2+ years Project management in medical technology​

(ISO 13485, IEC 60601-1)

Daniel Wehrwein

Senior Project Manager

8+ years technical project manager in medical technology

10+ years in R&D in medical technology

(ISO 13485/ IEC 60601-1/etc.)

Suman Bhunia

Business Strategy Advisor

Vivian Maretina

Innovation Manager

Daniel Gross

Sales and Operation

Accomplish more together with AX1 Medical now!

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