Quality and Environmental Management System

Biorapid GmbH has introduced a quality management system in the following areas:

  • Development
  • Manufacturing
  • Distribution

according to EN ISO 9001 (quality management), EN ISO 13485 (quality management medical devices) and EN ISO 14001 (environmental management).

There is no certification for EN ISO 14001. Biorapid GmbH operates internally an environmental management system oriented according to DIN EN ISO 14001.

For the ISO certificates, please refer to the certification of our OEM: