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