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, Operations or Clinical. 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.”
– 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.”
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”
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.”
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.”
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.
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