Site de l'université de Franche-Comté

Biotika® is the result of a very original approach: Integrate a virtual company in an engineering school which is a component of a University. Stepping stone to professional life, the company aims to introduce engineer students to various aspects of their future profession and put them in real work situation by developing real innovative projects for biomedical.

Its legal status is that of an internal company of ISIFC, itself component of the University of Franche-Comté. It received in September 2012, the ISO 13485 certification for the development of projects and technical and regulatory assistance for medical devices or any other device in the service of health. This is probably a world first!

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Integration within the ISIFC

Projet Digiteck

ISIFC because it is also a teaching module of 230 hours of training spread part-time on the second (1 day per week) and the third year of engineer studies (1.5 days / week).

The team consists of 35 people, including 25 engineer students ISIFC. It is the only French company to change almost its entire staff every year ! Only five positions are held by permanent members (management, human resources, quality, regulatory affairs, and project management). These permanents come from different horizons : education and academic research, hospital and corporate world. This professional diversity is the strength of this innovative company.

Its aims are:

  • A better understanding of industrial logic by students,
  • a concrete situation with real examples.
  • The development of medical devices in connection with the actors of health facilities and real needs.

It's also a pre-incubation cell for innovative projects in health technology mainly seeking efficiency and simplicity of the solutions, taking into account at the outset of regulatory, economic, ethical and clinical issues.

A Study Office for Innovative Medical Devices (IMD)

Biotika ® is not intended to produce or to manufacture.

This is an engineer firm specializing in medical device and health products that works with manufacturers or distributors. The purpose of the virtual enterprise is to accelerate the placing on the market of innovative biomedical products such as demonstration work (proof of concept and experimental or numerical prototypes) or as technical and regulatory assistance.Their clients are health professionals (researchers or caregivers) or industrial associations or patients.

16 projects have been implemented since 2006 ...

An ISO 13485 certification, like no other!

In September 2012, Biotika ® has been certified ISO 13485 (management systems (QMS) for the medical device industry) by the certification body LNE / G-MED on the following wording : "Development of projects including in the form of technical and regulatory assistance for health, based on skills and physical and electromechanical measurement ".

Biotika ® and is recognized as a true company controlling its system of quality management.