The successful registration of your medical device relies upon the provision of sufficient clinical evidence that demonstrates its safety and performance. Once in market, the generation of clinical data and its subsequent evaluation is an ongoing process. As such, clinical evaluation and clinical investigations are not just important parts of the initial journey to delivering your device to market, but are also key to keeping it there.
Should you require support in demonstrating or confirming the safety and performance of your device (either pre-market or post-market), our Clinical team offers a variety of services that cover the entire lifecycle of your device.
We offer a smart approach to clinical strategy, providing practical solutions to help you maximise budget and minimise timelines. We are also committed to achieving success for our customers, so our clinical evaluation documentation is consistently comprehensive to facilitate a smooth pathway to device registration.
Every device is different, so whether you require our support with clinical strategy or evaluation, we ensure our approach is tailored to what your project requires. Take a look at our service portfolio below.
Our Clinical Services
Clinical trials and data collection can be extremely costly and time consuming.
Our pragmatic approach to defining your clinical strategy will ensure patient safety whilst minimising time to market – be that in Europe or globally.
Clinical Evaluation MDR 2017/745 Annex XIV
To facilitate the registration of your device, your clinical evaluation needs to be comprehensive.
We can advise on and prepare your Clinical Evaluation Plan (CEP) and Report (CER) and support you with the preparation of your Post Market Clinical Follow-Up (PMCF) plan and PMCF reports. Should it be required, we can also help with your Summary of Safety and Clinical Performance (SSCP) as necessary.
Clinical investigations MDR 2017/745 Annex XV & ISO14155:2020
We can prepare your Clinical Investigation Plan and other essential documents as required for international submission to authorities and ethics committees for first-in-man, feasibility, pivotal or PMCF trials.
Our Clinical team also offers medical writing services that can support the publication of your study results in peer-reviewed journals.
– 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.”
“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.”
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.”
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
MedTech news roundup May
This month’s MedTech news includes guidance from the MDCG on significant changes under IVDR, new ordinances from the Swiss Federal…
Leveraging Real-World Evidence in medical device regulatory submissions
Providing data from randomized controlled trials has long been considered the gold standard to demonstrate the safety and efficacy of…
MedTech news roundup April
This month’s roundup includes an update on the EU Commission’s joint implementation plan for IVDR, guidance from the MDCG on…
MedTech news roundup March
This month’s roundup covers tackling medical device supply shortages in Switzerland, advice on direct procurement of foreign medical devices into…
Navigating Clinical Evaluation for SaMD
Clinical evaluation is an ongoing process that’s conducted throughout the life cycle of a medical device. It is a structured,…
MedTech news round up February
This month’s round up covers MDCG guidance regarding IVDs, an update from the EU Commission on the IVDR implementation plan,…
Subscribe to our monthly knowledge update