Quality and Regulatory Affairs

The vocation of Biotech International is to design, manufacture and distribute medical devices, equipment and implants relating to orthopaedic and dental surgery.

Biotech International wants to listen to surgeons, dental surgeons and pharmacists, both in France and abroad, in order to offer them products which continually meet the requirements of their profession and their wishes whilst complying with European and international standards and regulations.

 In order to meet this objective, the company committed itself to a quality approach ten years ago, an approach based on quality management, whilst adhering to the requirements pertaining to medical devices.

The quality policy, based on listening and client satisfaction, technological innovation and product quality, constitutes the pillar which ensures the progression of Biotech International along this path.

The quality department implements and maintains the quality system in compliance with the reference systems NF EN ISO 13485 (2004) and ISO 9001 (2000).

Within this framework, the regulatory affairs department ensures the quality and safety control of products marketed. It ensures adherence to traceability principles from the time the product is designed until it is used by the client.

The Medical Devices Vigilance Manager is responsible for the processing of incident and medical devices vigilance notifications in order to guarantee the sanitary safety of patients and users.

In order to submit your incident notifications to us as quickly as possible, you can fill in our form directly and send it to us :
- By fax to the following number : +33 (0)4 90 44 60 61
- By mail to the following address :