CE-IVD Certification
VarSome Clinical is clinically-certified as an In-vitro Diagnostic Medical Device according to the requirements of EC 98/79/EEC.
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.
We are certified with ISO 13485 quality management system for medical devices, and we are currently in the process of becoming certified to the ISO/IEC 27001 international standard for information security.
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.
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.
VarSome Suite is brought to you by Saphetor SA.
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