Our Standards
Quality and compliance are how we build - not a box to tick.
AdvantCare® is a medical-grade platform. Security, quality and compliance are manage datplatform level and guaranteed across the whole system - so every organisation that adopt sit inherits the same standards from day one, with no additional burden on its own teams.
Certified, qualified and verifiable.
Certifications and qualifications
The platform is built to the standards the sector demands, and holds the certifications and qualifications that let you verify it - not as a list in the legal footer, but in the open.
EU MDR
Certified under the European Medical Device Regulation.
CE MDR
UK MHRA
Certified for the United Kingdom market.
ISO 9001
Certified quality management system.
ISO 13485
Certified quality management system for medical devices.
ISO 27001 (with extension ISO 27017 and ISO 27018)
Certified information security management, extended for cloud security (27017) and the protection of personal data in the cloud (27018).
GDPR
Compliant with the EU General Data Protection Regulation.
UK GDPR
Compliant with the EK General Data Protection Regulation.
NIS2
Compliant with the EU NIS2 directive on network and information security
FDA
(SFDA available soon)
HIPAA COMPLIANT
ACN QC1
Qualified under Italy’s ACN QC1 for public-sectorentities.
Swiss DSG
Tier 4 data center in Europe
Patient data hosted in a Tier 4 data centre, in Europe.
How we handle data
Where your data lives, and who can reach it.
Security and compliance are handled by the platform, not delegated to a single module or to the customer. The resultis a governed perimeter that holds end to end.
Where it resides
Patient data is hosted in a Tier 4 data centre in Europe, with data redundancy for continuity and protection.
How it’s protected
Encrypted communications, two-factor authentication, and access controls that follow recognised security best practices.
Who can access it
Role-based access, so each professional sees only what their role requires
Why we collect it
Every data point has a declared function in the care pathway: we collect the clinical data because, without continuity of measurement, there is no evidence of therapeutic benefit.
Have a compliance question? Let’s answer it.
A conversation with a specialist: bring your security, procurement or data-governance requirements, and we’ll show you exactly how the platform meets them
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