Certifications at BAYOOMED

BAYOOMED works within a quality management system certified to ISO 13485 and applies ISO 27001 for information security.

BAYOOMED Medical Software - Zertifikate unsere Leidenschaft für MedizinprodukteBAYOOMED Medical Software - Zertifikate unsere Leidenschaft für Medizinprodukte

BAYOOMED Certifications

BAYOOMED operates under a quality management system certified to ISO 13485 and an information security management system certified to ISO 27001.

BAYOOMED Medical Software - Zertifikate unsere Leidenschaft für Medizinprodukte

And this is also confirmed by TÜV Hessen. This is because Our quality management processes are certified to ISO 13485 and designed to be MDSAP-compliant.

This quality policy obliges us to develop secure, reliable and equally innovative software solutions. At the same time, we do not lose sight of the user experience.

BAYOOMED - Unsere 13485 Zertifizierung

Our processes

We work with state-of-the-art technology and at the same time always keep an eye on the latest applicable standards and guidelines.

Software Engineering and Verification in Accordance with IEC 62304 / IEC 82304

Risk management according to EN ISO 14971

Usability / Human Factors Engineering in accordance with IEC 62366 and “Applying Human Factors and Usability Engineering to Medical Devices”

Cybersecurity risk management in accordance with IEC 81001-5-1 and AAMI TR57 (for FDA)

Validation according to GAMP5