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confinis ag

Biotech — Diagnostics — Digital health — Medical device — Service provider —

Contact person

Dr. Heidi Horsch

Phone

+41 26 494 8 494

Mobile

+41 78 740 91 25

Address

Allee 1B, CH-6210 Sursee

Employees

18

Established

2005

confinis – 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.

confinis is a global regulatory affairs and quality management consulting firm specializing in medical devices, combination products and in-vitro diagnostics based in Switzerland and the USA.

Our range of services includes:

● Regulatory affairs

● Design control

● Quality Management systems incl. maintenance and optimization

● Risk management

● Usability engineering / human factors studies

● Clinical evaluations

● Postmarket surveillance

● Auditing and training

Additionally, we offer our innovative approach to the modular construction of Design History Files (DHF), enabling a quantum leap in the maintenance of DHFs. Depending on the customers’ needs, we provide support throughout the product development process and post market surveillance operations; or we support certain aspects like regulatory strategy development or the design control process. Our consultants hands-on experience enables confinis the ability to offer unique and wide-ranging services related to designing and manufacturing medical devices, combination products and in-vitro diagnostics.

Looking for efficient and effective advice on medical devices, combination products and in-vitro diagnostics? confinis’ scale in its services to you, is getting it right the first time!

Visit our website www.confinis.com and follow us on LinkedIn and @byConfinis

confinis is an enterprise member of the Regulatory Affairs Professional Society: RAPS