We have a Quality Management System certified according to EN ISO 13485:2016 "Medical Devices - Quality Management systems - Requirements for regulatory purpose" by TÜV Product Service, Munich, Germany.
The scope of the certificate is "Design and development, production and distribution of products, reagents, and instruments for in-vitro diagnostic use".
  EN ISO 13485:2016
The ISO13485:2016 is an internationally recognized standard for organizations involved in the medical device industry. This standard specifies the requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and regulatory requirements.

Hence the ISO 13485 certification is a proof of Quality Management System compliance to the standard for organizations involved in the Medical Device industry. Therefore, the decision was taken to not renew ISO9001 certification.