WHITEPAPER

Certifications and Compliance

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. 

  • CE-IVD Certificate
  • HIPAA Compliance
  • ISO 13485 / ISO 27001
  • GDPR Compliance
  • Hébergeur de Données de Santé
cert-cover

Download Now!

Certifications and Compliance

Download Now!

CE-IVD Certificate

CE-IVD Certification

VarSome Clinical is clinically-certified as an In-vitro Diagnostic Medical Device according to the requirements of EC 98/79/EEC.

 

HIPAA Compliance

HIPAA Compliance

All VarSome products and services are fully compliant with the Health Insurance Portability and Accountability Act (HIPAA) requirements.

ISO 13485 / ISO 27001

ISO 13485 / ISO 27001

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.

GDPR

GDPR

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

Hébergeur de Données de Santé

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.