Medical Device Consulting in Switzerland from Congenius

Web Name: Medical Device Consulting in Switzerland from Congenius






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 SMEs 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 70 valued customers to complete over 300 successful projects.

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

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




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



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

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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.

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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.

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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.

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Sufficient clinical evidence that demonstrates the safety and performance of a medical device is a fundamental requirement for device registration. Our Clinical team at Congenius can support you with smart clinical strategy, thorough planning of your clinical investigations and comprehensive clinical evaluation to enable you to successfully deliver your device to market.

Find out more
300 successful projects 73 valued customers 33 talented employees 15 years’ experience on average across the team 5 medical device consulting excellence areas


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

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

Susanna Jinks

Director RA

“I have been collaborating with Jörg and his teams for several years across different organisations in both RA and QA areas. The level of professionalism, customer service, integrity, knowledge and skills is outstanding and set him and Congenius apart from most. I can personally recommend Congenius and Jörg’s team that I have been working with, it’s been a pleasure and an enriching experience.”

Nobel Biocare

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.”


Johannes G. Bremmers

Vice President Quality Assurance & Regulatory Affairs

“Jörg and his team have helped us to address several challenges from improving our quality system to re-engineering and validating manufacturing processes and implementing software tools. In these projects Congenius has demonstrated: a broad field of competences, a strong commitment to customer service as well as the ability to apply pragmatic solutions for difficult problems. Their patient but persistent approach is a basis for a pleasant and fruitful relationship. I recommend Congenius as an all-round Quality and Regulatory contractor for the MedTech industry.”


Bianca Hedari

Director of Quality

“We managed to improve our Quality Management System with the support of Congenius. Specifically, we have been able to achieve substantial and sustainable progress in our processes and key quality indicators, especially as it relates to our CAPA & Post Market Surveillance areas. In addition to this, Congenius has been of key support in upskilling our employees and ensuring we are internally set up for success going forward. Since we first brought Congenius on board, we have made good strides, which has been noticed both internally and by our regulatory partners.”

Medela, Switzerland

Bianca Hedari

Director of Quality

“Having worked with many consulting agencies in the past, the difference with Congenius is clearly in its people who work with passion and a commitment to excellence. I can say without a doubt that my interactions with Congenius personnel have been fantastic, both from a knowledge & skillset standpoint, as well as their integrity & character. It is a pleasure to work with them and we would not be where we are today without their support. I wholeheartedly recommend them to any organisation looking to take their Quality Management System to the next level.”

Medela, Switzerland

Andreas Bakmeier

Managing Director

“As a manufacturer of medical products, we depend on a competent partner in the demanding regulatory environment, who can support us promptly and creatively. In Mr. Dogwiler we have not only found the right sparring partner to support us in the creation of our quality management system and a consultant to assist with external audits, but have also learned to appreciate him more and more in the course of working together because of his personality, and his ability to approach things pragmatically. We are looking forward to our further cooperation and can highly recommend Congenius as a reliable partner.”


Michael Fechtig

Quality Management Specialist

“For me it’s the perfect collaborative mix. The experts at Congenius do not only provide theoretical knowledge, but also help with practical implementation. The cooperation was very productive and resulted in clearer and more workable processes. Both the communication within the project and on administrative issues was always very fast and efficient. We will continue to work with Congenius to continue benefiting from their expertise.”

Bruker Switzerland AG

Team Leader Quality Engineering

“Initially Congenius supported me personally as a QMS consultant and later as a contractor for Operational Excellence Experts. They always provided me with strong and reliable support during critical time periods. What I appreciate most is the combination of maintaining values such as trust, integrity, and speaking up, and providing feedback on the highest level whilst working in a highly professional setting. For me Congenius is an outstanding MedTech consultancy and I am looking forward to solving prospective challenges together in future.”

Global Diagnostic Company

News & Knowledge

What’s New

EUDAMED roundup | What’s happened and what’s next

The creation of a European database for registering certified medical devices is regarded as a cornerstone of the EU MDR…

Read more What’s New

MedTech news roundup July 2022

Our July MedTech news roundup includes an IVD notification FAQ from Swissmedic, MDCG guidance on interim solutions for IVDR in…

Read more What’s New

How to calculate the Analytical Evaluation Threshold for your Biocompatibility Assessment

The Analytical Evaluation Threshold (AET) is the crucial parameter for demonstrating that your analytical results sufficiently assess the biological safety…

Read more What’s New

Congenius Whitepaper | How to develop SaMD

As health care advances, software has become integrated widely into digital ecosystems that serve both medical and non-medical purposes. To…

Read more What’s New

MedTech news roundup June 2022

Our June MedTech news roundup includes a notice from the EU Commission on the EU-Swiss MRA status for IVDs, advice…

Read more What’s New

Consultant Spotlight – Charlotte Berg

Charlotte Berg joined us in July last year as a Senior Consultant in Operations. In her Consultant Spotlight below, Charlotte…

Read more

Subscribe to our monthly knowledge update

Stay informed and up to date with the latest industry news delivered direct to your inbox. By subscribing to our monthly newsletter, you will also gain access to our full range of topical content produced by our MedTech industry experts across the Quality, Regulatory, Clinical, eHealth and Operations fields.

Our Partners



Contact Us

Congenius AG
Riedstrasse 1
CH-8953 Dietikon

E: [email protected]

T: +41 44 741 04 04


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: [email protected]
t: +41 44 741 04 04


a demo

Find out more about QMgeniuS by requesting a demo.

Simply fill out your details and click “Request a demo", then a member of the team will get back to you shortly.

Alternatively, feel free to give us a call on +41 44 741 04 04 to start the conversation. We look forward to hearing from you!


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