During our last five years of existence, we have formed trusted partnerships with global firms, established SME`s and aspiring start-ups in the medical device, in vitro diagnostics and pharmaceutical industry.
We have helped over 50 valued customers to complete over 170 successful projects by providing tailored expertise and leadership as required. So, whether you are seeking support with a fundamental business need or looking for a skillset to complement your internal workforce, we can provide reassurance through our knowledge and experience that will facilitate the successful delivery of your project.
Having worked with a wide range of Start-ups, we are well prepared to help you tackle the regulatory challenges that can often be as unique as your business itself. Our broad knowledge base across our service offerings aims to support the enhancement of your core business, and by using validated approaches, we ensure cost and time efficiencies to maximise your budget. Our aim is to provide reassurance and direction as you look to make your mark on the industry.
Established small to medium enterprises
Our knowledge is steeped in broad experience, which allows us to offer a varied perspective to address your needs in the fields of Quality, Regulatory, eHealth or Operations. We always look to complement your internal workforce and challenge you to develop and grow in the smartest way possible.
We have established long-term and respected partnerships with global firms. After immersing ourselves in a project quickly, we then challenge when necessary, whilst remaining pragmatic, focussing on finding the most appropriate solution. Our specialist knowledge will always be tailored to the requirements of each of your individual medical device or combination product projects.
– 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.”
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