About confinis

confinis logo

confinis is a global consulting firm in the field of medical devices, in vitro diagnostics and combination products based in Switzerland and the USA. Our range of services includes regulatory affairs, quality management, design control, risk management, usability engineering/human factors, clinical evaluation, labelling, manufacturing, process validation, supply chain, post-market monitoring, auditing, and training. Our experienced and highly motivated team consists of electrical, mechanical, software, and biomedical engineers, as well as physicists, pharmacists, medical doctors, chemists, biochemists, biologists, and biotechnologists.

We have mastered the theory, but we still see ourselves as practitioners who have learned from scratch. Our knowledge and skills, based on theoretical foundations, are rounded off with years of practical experience. As a partner, confinis offers its clients pragmatic and workable solutions.

 

Efficient and effective advice on medical and combination products is not rocket science — it just needs well-founded and updated knowledge as well as decades of experience!

About our name

Our name stands for our business model — confinis comes from Latin and means, among other things, adjacent, adjoining, the missing particle. We want to fill the place of the missing particle in your businesses and attain success together.

About our clients

Our clients in this area often lack experienced project managers in development or specialists for design control, clinical evaluations, human factors or risk management. We also provide training, optimize the supply chain process and assist in obtaining respective market authorizations.

We have accompanied numerous start-ups, built the quality management system and obtained the necessary market authorizations. It is important to us that the entrepreneurs can concentrate on the core idea and not be distracted by the sidelines – with us you are in safe hands!

For many of our customers in this segment, we serve as an external quality management department, which is also responsible for global registration activities. Here we create and maintain the technical documentation, including risk management and are responsible for the post-market surveillance.

Together we are strong! Especially in our industry, it is often the case that we have too little manpower available or that the necessary specialist knowledge is not there. Here we cooperate on a project to project basis with independent specialists from our network or offer our services to other consultancy firms.

Overview

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How can we help you?

Call us at a confinis office nearest to you or send us a message online.

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!

Yvette Viscuso
Managing Director, Peschke Trade

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