Certifications

BAYOOMED operates under a quality management system certified to ISO 13485.

BAYOOMED Medical Software - Zertifikate unsere Leidenschaft für Medizinprodukte

BAYOOMED Certifications

BAYOOMED operates under a quality management system certified to ISO 13485.

And TÜV Hessen confirms this as well. Because u Our quality management processes are certified to ISO 13485 and designed to be MDSAP-compliant.

This quality policy commits us to developing secure, reliable, and equally innovative software solutions. At the same time, we never lose sight of the user experience.

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Our Processes

We use state-of-the-art technology while always keeping the latest and most current standards and guidelines in mind.

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 the FDA)

Validation According to GAMP 5

Information Security Management System in accordance with ISO/IEC 27001

Miriam Schulze
CEO

Reaching Your Goal in Compliance with Regulations

With our ISO 13485-certified quality management system and established processes that comply with the relevant standards, we not only create a reliable foundation for your medical software, but also guide you safely through the approval and market authorization processes.

How can we support your project? Feel free to reach out to us—together, we’ll find the right path to your medical device or digital health application.