Regulatory
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
Regulatory Strategy
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.
Medical Device Reimbursement
Effective reimbursement strategy for medical devices increases market access, boosts competitive advantage, and encourages the adoption of innovative MedTech.
In collaboration with our partner MArS, we offer enhanced solutions for market access strategies and implementation within the D-A-CH region, the US, and Canada. Together, we can support startup organisations and established companies with the preparation of reimbursement dossiers, participation in consultation procedures & hearings, pricing negotiation with health authorities & insurance providers, pricing analysis & health economics modelling, and stakeholder engagement including direct contracting with individual payers.
Sustainability Compliance
Via our partner network, we provide tailored solutions that enable businesses to confidently adapt to the key regulatory sustainability requirements for the medical device industry, whilst gaining a sustainable competitive advantage.
Together with our sustainability partner, we support companies in navigating the European Green Deal framework, including identifying and implementing CSRD and CSDDD requirements, integrating sustainable practices throughout the value chain, adapting to new ecodesign regulations under ESPR, and embedding sustainability strategies.
Resources
News & Knowledge
Subscribe to our monthly knowledge update