
As a digital health company developing software as a medical device (SaMD), Tesu Health designs and operates regulated products in accordance with recognised standards for information security, privacy, clinical safety and quality management. Our assurance programme reflects a risk-based, security-by-design approach across the full product lifecycle.
Compliance Frameworks
Frameworks

Cyber Essentials
Cyber Essentials certification scheme (Willow v3.2)

DCB0129

NHS Digital Clinical Safety for Manufacturers
Clinical Risk Management Plan
Clinical Safety Case Report
Hazard Log for PreDiaWell
Published hazard log for PreDiaWell
DSPT

NHS Data Security and Protection Toolkit (Category 3 Organisation / Other)

DTAC

NHS Digital Technology Assessment Criteria
NHS DTAC Form - PreDiaWell

GDPR
General Data Protection Regulation
PreDiaWell - Data Protection Impact Assessment

ISO 27001:2022


Information Security Management Systems