Certifications in Healthcare

Hospitals, practices, suppliers of medical products – they are all hugely important for the common good. And so it is also part of everyday business in the healthcare sector to deal with issues relating to energy and environmental management, occupational health and safety, and, in particular, the important area of quality management.

Berlin Cert is part of GUTcert since 2016.

This enables us to provide competent service to customers in this sensitive area of medical products from a single source. Please contact us or our colleagues at Fanny-Zobel-Straße and request a non-binding quote.

• Certification of Quality Management Systems according to EN ISO 13485
• Conformity Assessments according to MDR
• IT Security Tests / Penetests
• Review of Digital Health Applications (DiGa)

ISMS Guidelines in Medical Technology (German) and Checklist (German)

All GUTcert publications can be found under Publications.