Certifications

What we are particularly proud of? On our sustainable business solutions and on the fact that we achieve the best results for you with our established processes.

And this is also confirmed by TÜV Hessen. This is becauseour quality management processes are ISO 13485 certified and 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 development and verification according to IEC 62304 / IEC 82304

Risk management according to EN ISO 14971

Usability / Human Factors Engineering according to 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