We are helping out with project managers in development or specialists for design control, clinical evaluations, human factors or risk management.
Small & mid.
We are serving as an external quality management department, which is also responsible for global registration activities.
We are accompanying start-ups, are building the quality management system and do obtain the necessary market authorizations.
We cooperate on a project to project basis with independent specialists from our network or offer our services to other consultancy firms.
confinis not only supplies expertise for regulatory challenges in combination products, but operates as a member of our team, driving and guiding complex regulatory processes and helping us to understand the requirements while building up our knowledge.
The project management Quality support provided by confinis was exceptional. The project included implementation and launch of a major biologic PFS for the US market with an aggressive timeline. Not only did we meet the project timeline, but we filed one month early. The support provided by confinis was instrumental in meeting and exceeding our goals. Well done!
Peschke appreciates the specialized expertise for regulatory challenges in the area of combination products. For us this missing piece is key to success to access the important US market. The professionality and expertise of confinis is overwhelming, and we can highly recommend them whenever FDA related topics occur – Great people behind a great business!
Whenever we intend to invest in a company that plans to sell medical devices or combination products we involve confinis in our due diligence process to assess the regulatory strategy, verify compliance with applicable regulations and challenge the time required to obtain marketing authorization. confinis’ expertise regarding EU and US requirements in this area is simply unrivaled and their dynamic and entrepreneurial team are a pleasure to work with.
We are very happy with our choice of confinis as a one stop shop QA/RA partner to Neo Medical, supporting our growth from a start-up to an international company. confinis has provided expertise in everything from quality management, design control, clinical evaluation, internal and supplier audits, CE marking, 510(k)s to global registrations. I highly recommend confinis!
June 25, 2018
June 19, 2018
June 11, 2018