Debiotech SA

Debiotech SA

Short description

Debiotech is an ISO13485 certified company, active in the development of innovative medical devices, with over 30 years of experience and know-how.

Standards, Products, Services

  • S ISO 13485:2016
  • S Product development
  • S Engineering services
  • S Technology development
  • S Application development
  • S Consulting
  • S App development
  • S Further development software, IT, electronics
  • S Computer system validation
  • S Standard compliant software development
  • S Embedded Systems Engineering
  • S Functional Safety
  • S Cybersecurity

About us

For over 30 years, we have been developing innovations for MedTech. 

Through the various medical devices, we have designed and licensed, we have developed unique skills and expertise.

It is therefore quite natural that we have chosen to share our entrepreneurial experience to accompany your developments. From the idea to the marketing of an innovative and compliant medical device (FDA 510k and/or CE marking), we are at your side.


What we offer

  • Research & Development: we take care of your technical development (software, mechanics, and electronics) while advising you.
  • Compliance: we accompany and guide you in the management of your project within the framework of a compliant medical device development process (eg. preparation of technical files for clearance submission). 


We follow one goal: Improving patient’s lives together.


Facts & figures:

  • over 20 different medical product developments (drug delivery, artificial organs, nephrology, cardiology, diabetes, …)
  • over 40 license agreements
  • numerous prestigious awards
  • more than 500 granted national patents
  • ISO 13485 certified QMS and following FDA 21 CFR Part 820 requirements
  • compliance with MDR regulations and requirements of ISO/IEC 62304, 60601-1, 62366, 14971, …