Together with our customers, we stimulate informed ideas, create lasting solutions, and inspire positive change.

Here at Congenius, we provide tailored expertise and leadership to global firms, established SME`s and aspiring start-ups in the medical device, in vitro diagnostics and pharmaceutical industry.

By reassuring our customers through knowledge and experience we form trusted partnerships that facilitate the successful registration and delivery of medical devices. Explore our site to find out more.

Our Services



Whether your challenge is quality management, engineering or assurance related, our highly skilled Quality team can help you discover the smartest solution.

Find out more here



We understand the importance of trustworthy advice in the regulatory field, so the knowledge we provide is steeped in experience. We can support you with regulatory strategy, technical compliance, worldwide registration and more.

Find our full list of Regulatory services here



Our eHealth team can provide diverse and adaptable expertise in the area of Mobile Applications, offering support in the development of Server Software Platforms for eHealth, mHealth and Digital Health.

Discover how we could help your business here



Our Operations consultants offer reliable support that helps to optimise the manufacture of medical devices and combination products. We can help ensure that your operational processes meet the necessary standards in this highly regulated field.

See our full Operations offering here


Bettina Ernst

– Co-Founder & CEO

“I found their creative but simple solutions for addressing non-conformity extremely helpful. There was no unnecessary work undertaken – just the provision of straight forward and proactive solutions. I needed matter of fact input; advice and tools that were lean and to the point. And that is exactly what I received. As a result, my understanding is now increased, and compliance has been achieved.”

Proponent Biotech

Sandro Venanzoni


“Working with Congenius was straight forward, helpful and efficient. As well as being very knowledgeable, they introduced us to useful tools that made our working lives a lot easier. Their positive attitude and uncomplicated ways of working kept things easy. Our collaboration allowed us to define our procedures and to improve efficiency and productivity, whilst finding pragmatic ways to ensure only the necessary work was completed.”


Daniel Krieg

– Product Management

“Jörg helped us to lay the groundwork for our documentation and organisational structure. Being quality driven and business savvy, he was a reliable source for knowledge and understanding – we always received clear explanations, and I don`t recall a single question he couldn`t answer! His patience and ability to apply give and take helped us to progress in a way that suited our business, and with his methodical and thorough approach he became a driving force toward delivery. Our partnership improved our company`s efficiency and quality – it was the best investment we made last year.”

Fipe System

Patrick Kugelmeier

Co-Founder & Medical Director

“Jörg has supported us in the process of getting our medical products approved. His experience, honesty and reflective thinking helped us to guide us effectively through the process. Jörg’s authentic commitment to customer service has helped to strengthen our working relationship. We see him as a true partner and will continue to work with Congenius.”


News & Knowledge

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    Get in touch

    If you have a challenge that you think we could help with, please feel free to get in touch by filling out our contact form or by giving us a call. We look forward to speaking with you!

    Congenius AG
    Riedstrasse 1
    CH-8953 Dietikon

    t: +41 44 741 04 04