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.

Contact

Posts (6)

Debiotech SA October 9, 2023
Video

Improving patient’s life through smart design & engineering

Drawing on the principles of smart design and engineering, we constantly strive in our developments to transform healthcare to be more effective, more efficient and more patient-centric, thereby improving patients' lives. We will be presenting our approach and concrete results.
Debiotech SA July 21, 2023
Know-How

How to cybersecure your medical device?

While cybersecurity is an important topic in many fields, it's a major issue for Medtech and medical devices. It's essential to put a strategy in place from the very start of your development, and to commit to a real discipline of follow-through.

Swiss Medtech Expo 2023
Debiotech SA July 3, 2023
Service

How we manage cross-platform application development?

Digital Health. At Debiotech, we have seen a rising need amongst our clients for mobile applications development, which means support for both Android and iOS.

Swiss Medtech Expo 2023
Debiotech SA September 29, 2021
Video

Remote Patient Monitoring - Technology to Improve Healthcare

Remote Patient Monitoring (RPM) is a technology requested and expected by both patients and physicians, with 2/3 of the latter having the firm intention to use it. Laurent Colloud, Software Project Manager at Debiotech, will present how this technology works and can be implemented in healthcare.
Debiotech SA August 3, 2021
Service

Medical Software Development Services

We help you at all levels of your medical software development to meet the technical, safety and regulatory requirements for CE marking and FDA’s 510(k) approval.

Swiss Medtech Expo 2021
Debiotech SA August 3, 2021
Showcase

Embedded Software in A Peritoneal Device

The medical device is an integrated system with an embedded software up to class C. The project highlights the know-how of Debiotech in putting in place a complete environment for the development and verification of the highest quality software.

Swiss Medtech Expo 2021

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, …