CE-IVD Certification
VarSome Clinical is clinically-certified as an In-vitro Diagnostic Medical Device according to the requirements of EC 98/79/EEC.
Learn how we ensure that your data is always protected and how we deliver business resilience with the right data protection and safety measures in place.
VarSome Clinical is clinically-certified as an In-vitro Diagnostic Medical Device according to the requirements of EC 98/79/EEC.
All VarSome products and services are fully compliant with the Health Insurance Portability and Accountability Act (HIPAA) requirements.
The General Data Protection Regulation (GDPR) is a regulation in EU law on data protection and privacy for all individual citizens of the European Union and the European Economic Area. As part of European law, compliance with the GDPR is not optional and at Saphetor we are fully committed to ensuring that it meets all of its requirements.
We are certified with ISO 13485 quality management system for medical devices, and certified to the ISO/IEC 27001 international standard for information security.
We are compliant with functional safety standard, IEC 62304 "medical device software - software lifecycle processes". It applies to the development and maintenance of a medical device software when:
- The software is itself a medical device.
- Or the software is an embedded or integral part of the final medical device.
Hébergeur de Données de Santé (HDS) provides a framework to strengthen the security and protection of personal health information in France, and we are fully compliant with it.
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VarSome Clinical is an AgID-compliant platform for use in the public health sector in Italy. Further information can be found here.