Quality Management System

Biotype is certified to meet DIN EN ISO 13485 and DIN EN ISO 9001 standards for the scope of sales, development, manufacturing and services of molecular tests for in-vitro diagnostic applications (ISO 13485:2016) and research and diagnostic applications (ISO 9001:2015).

The established quality management system ensures that the products and services meet all customer and regulatory requirements. Thereby, the company is able to provide its customers highest quality standards.

The certificates can be downloaded here:

ISO 13485 Certificate

ISO 9001 Certificate