“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 Offer

Robust Knowledge

Tailored Expertise

Varied Experience

Each of our Congenius consultants has on average ten years of MedTech industry experience across a diverse range of fields. During our last five years of existence, we have supported over 50 valued customers to complete over 170 successful projects.

We offer tailored expertise across Quality, Regulatory, eHealth and Operations.

Find out more about our breadth of excellence areas here.

Our Method

Strategic thinking

Hands on hard work

Highly adaptable

At Congenius, we balance the goals of our customers with the requirements of the appropriate regulatory frameworks, to ensure we facilitate the successful registration and delivery of medical devices. We work hard with our customers to implement intelligent solutions defined by our strategy.

The Medical Technology industry is constantly evolving, and so we consider adaptability as a necessary state of mind. Our recruitment process selects only those people who have this adaptable mindset, and we invest in training and resources to facilitate continuous improvement amongst our team.

Find out more about how we work here.

Our Approach

Smart

Pragmatic

Customer-focused

For us, being smart is about taking the most lean, efficient, intelligent, or creative journey as required to arrive at a solution that really works. Along the way, we are rational, reasonable, and reliable to ensure as smooth a process as possible.

With a truly customer-focused approach, we focus on delivering solutions that align with our customers` long-term business strategy.

Learn more about the customers we’ve helped to date.

Our Services

Quality

Quality

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

Regulatory

Regulatory

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

eHealth

eHealth

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

Operations

Operations

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

Testimonials

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

– CTO

“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.”

Tri-implants

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.”

Kugelmeiers

News & Knowledge

Subscribe to our monthly knowledge update

Stay informed and up to date with the latest industry news delivered direct to your inbox. You can tailor your preferences to prioritise what you`d like to hear about each month; be it quick round ups of new standards, fact sheet resources on the latest regulations or longer articles covering timely topics across the wider MedTech industry.

    ×

    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

    e: info@congenius.ch
    t: +41 44 741 04 04