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Certifications and clearances

To offer the best support to our partners, we set up dedicated
processes for the development of Software as Medical Devices
and ensure that they comply with regulatory requirements
in terms of quality and working methods.

Certifications

  • ISO 13485

Medical Device Quality Management System

View certificate

  • MDSAP US / Canada

Regulatory audit for the requirements of the regulatory authorities in the U.S, Canada, Japan, Brazil and Australia

View Certificate

  • IEC 62304

Software Development Lifecycle Management

  • ISO 14971

Risk Management for Medical Device

  • IEC 62366

Usability & Human Factors Engineering of Medical Device

  • ISTQB

International Software Testing Qualifications Board

  • HIPAA

Health Insurance Portability and Accountability Act compliant

  • GDPR

General Data Protection Regulation compliant in the European Union

Clearances

  • 510 (K)

5 clearances obtained for our Medical Devices in the US in oncology and diabetes

  • CE Mark

8 clearances obtained for our Medical Devices in the European Union in oncology and diabetes

  • Health Canada

1 clearance obtained for one of our Medical Devices in Canada in diabetes