“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.
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.
Hands on hard work
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.
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.
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
– 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.”
“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.”
– 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.”
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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A guide to De Novo registration
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