Product performance and patient safety are paramount within the Medtech and Pharmaceutical industry. At Congenius, we understand the importance of trustworthy advice in the regulatory field, so our Regulatory team provides our customers with knowledge that is steeped in experience.
It can be difficult to find the right personnel at the right time to tackle a challenge, so we ensure that all our Regulatory consultants can easily integrate into your internal teams, providing skills specific to your requirements. We recognise that our industry is ever evolving, so we invest in continuous training for our consultants, ensuring a high level of adaptability.
Our aim as your Regulatory experts is to help you ensure safe practices and to develop products with efficacy. We achieve this by providing the knowledge and skills necessary to reassure you that you’re taking the smartest route to delivery and registration. Read more below about how we can support you with regulatory strategy, technical compliance, worldwide registration, post market surveillance and more.
Our Regulatory Services
If you are in the process of developing a medical technology or combination product, we can help you to develop the smartest regulatory strategy to ensure a smooth journey to delivery and registration.
We are able to advise you on product classification and relevant approval procedures appropriate to the countries in which you require approval.
Our knowledge spans international governing bodies, and so regardless of whether product approval is required in Europe, the US or elsewhere, we can help you set the right regulatory course from project inception.
General Safety & Performance Requirements (GSPR)
For a medical technology product registration within Europe, the general safety and performance requirements (GSPR) according to Annex I MDR 2017/745 must be met.
We would be happy to advise you on the relevant requirements necessary for your product, and the harmonised standards in which these are covered. With our thorough evaluation, you will be able to consider all essential requirements during the design input phase of your project, resulting in peace of mind that conformity will be ensured.
Compilation of Technical Dossiers DHF, DMR
A smooth product registration relies on the compilation of compliant technical dossiers.
We can support you in the creation of a product file that encompasses your results from design input, design output, design verification, design validation and design transfer. We are able to compile your technical files in accordance with STED (Summary TEchnical Document) based on your development results. Our aim as we assist in this area is to reassure you as you prepare for your product registration.
Product Registrations CE, FDA, RoW
If you are looking to register your medical device for market entry in Europe (CE), the US (Listing, 510(k), PMA) or elsewhere, we can manage, implement, or collaborate on the procedure as needed.
If required, we would be happy to take on the registration work on your behalf from start to finish. This would span the preparation of technical documentation, ensuring that your processes within the quality management system are compliant, making the submission to the notified bodies and liaison with these bodies as needed until the device certificate has been issued. Together, we can take an intelligent and straight-forward path to product certification.
Post Market Surveillance & Vigilance
Post Market Surveillance (PMS) comprises the collection of information about the properties of medical devices regarding their post market use (safety, quality, shelf life, performance), the evaluation of this data in a periodic report (PMS Report or PSUR), the implementation of any corrective actions which may be required for the device and where necessary, the planning and implementation of field safety corrective actions (FSCA).
If you would like to market your medical device as a manufacturer or distributor, once in market, you will be required to notify the relevant authorities of any serious incidents, recalls or other field safety corrective actions (FSCA). We can support you in this area by helping you to implement a process for Post Market Surveillance, including guidance on how to correctly notify the authorities in accordance with MDR and MEDEV 2.12-1 guidelines, for use in the unfortunate event of a serious incident.
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…
Using Digital Health Technologies for Remote Data Acquisition in Clinical Investigations
Last month (December 2021) the FDA published draft guidance regarding Digital Health Technologies for Remote Data Acquisition in Clinical Investigations.…
Preparing your Premarket Submission for Device Software Functions
The FDA has recently published draft guidance regarding the content of premarket submissions for device software functions. The guidance provides…
MDR adherence | MDCG guidance for Clinical Affairs
Keeping track of the ongoing guidance for MDR adherence can be a time-consuming task. So to simplify your information-gathering process,…
8 tips for producing effective MDR Technical Documentation
Producing effective Technical Documentation provides manufacturers with their own central information source regarding their medical device. Accurate Technical Documentation can…
How to determine legitimate FDA approval
Within the medical devices field, you may have come across terms like “FDA registered”, “FDA certified” and “FDA Registration Certificate”.…
– MDR Program Manager
Congenius provides us with Regulatory Affairs and technical writing support, delivering a consistently reliable quality of output. I found the communication with Mr Dogwiler regarding needs and candidates to be efficient and time-saving, and the consultants that I work with are proactive and highly skilled. The Congenius team members really took a significant workload off my shoulders and made progress in a very transparent way without the need for continuous steering – thank you for this!
– 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
Congenius welcomes Bruno Gretler as new Head of Regulatory & Clinical
We are delighted to welcome our new Head of Regulatory & Clinical to the Congenius team. Bruno Gretler joins us…
MedTech news roundup | January 2024
Our January MedTech news covers a broad range of recent guidance and updates from the EU, Switzerland, the US &…
MedTech news roundup November 2023
Our November 2023 MedTech news roundup covers guiding principles on PCCPs, information from Swissmedic on vigilance reports for medical devices,…
MedTech news roundup October 2023
Our October 2023 MedTech news roundup covers the Swiss Federal Council’s amendment to MedDO and the EU Commission’s Q&A on…
Artificial Intelligence in medical devices
Artificial Intelligence (AI) has the potential to revolutionise the healthcare industry by enhancing diagnostic accuracy, treatment efficiency, and patient care.…
MedTech news roundup September 2023
Our September 2023 MedTech news roundup includes updates from Swissmedic on Swissdamed, from the EU Commission regarding the extended MDR…
Subscribe to our monthly knowledge update