ISO Certification

Bioanalytic GmbH is fully certified in accordance with EN ISO 9001 (quality management) and EN ISO 13485 (quality management medical devices) in all areas:

• Development
• Manufacturing
• Distribution

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

Below are the certificates for EN ISO 9001 and EN ISO 13485 as well as information on the supplier evaluation.