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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 Certification
  • IVDR in progress for May 2023
  • HIPAA Compliance
  • ISO 13485 - Quality Management Systems for Medical Devices
  • ISO 27001 - Information Security Management
  • IEC 62304 - Software Life Cycle Processes for Medical Devices
  • GDPR Compliance
  • AgID Certification
  • Hébergeur de Données de Santé Compliance
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Certifications and Compliance

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CE-IVD Mark

CE-IVD Certification

VarSome Clinical is an In-vitro diagnostic medical device compliant with the Regulation (EU) 2017/746 (IVDR).

 

HIPAA Compliance

HIPAA Compliance

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

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.

ISO 13485 / ISO 27001

ISO 27001 Certification

Saphetor considers the protection of the data as very important, and has demonstrated it through its compliance to the ISO27001:2022, which is the latest update of the standard related to the Information Security Management System.

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ISO 13485 Certification

As part of the compliance to the IVDR, Saphetor has implemented a Quality Management System for medical device manufacturer that is compliant with ISO 13485:2016/A11:2021.

Hébergeur de Données de Santé

Hébergeur de Données de Santé

Saphetor's datacenters are certified HDS (Hebergeur de Données de Santé), which provides a framework to strengthen the security and protection of personal health information in France, which Saphetor is fully compliant with it.

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