
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 (Danzell v3.3)
DCB0129

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

NHS Data Security and Protection Toolkit v8 (25/26) (Category 3 Organisation / Other)
DTAC

NHS Digital Technology Assessment Criteria (v2)
NHS DTAC Form - PreDiaWell
GDPR
General Data Protection Regulation
PreDiaWell - Data Protection Impact Assessment
ISO 27001


ISO 27001:2022 Information Security Management Systems