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
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ISO 13485
Medical Device Quality Management System
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MDSAP US / Canada
Regulatory audit for the requirements of the regulatory authorities in the U.S, Canada, Japan, Brazil and Australia
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IEC 62304
Software Development Lifecycle Management
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ISO 14971
Risk Management for Medical Device
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IEC 62366
Usability & Human Factors Engineering of Medical Device
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ISTQB
International Software Testing Qualifications Board
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HIPAA
Health Insurance Portability and Accountability Act compliant
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GDPR
General Data Protection Regulation compliant in the European Union
Clearances
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510 (K)
5 clearances obtained for our Medical Devices in the US in oncology and diabetes
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CE Mark
8 clearances obtained for our Medical Devices in the European Union in oncology and diabetes
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Health Canada
1 clearance obtained for one of our Medical Devices in Canada in diabetes