Skin Analytics’ DERM is the only Class IIa UKCA marked and Class III CE marked AI as a Medical Device for skin cancer

Skin Analytics’ DERM is the only Class IIa UKCA marked and Class III CE marked AI as a Medical Device for skin cancer. In addition to being regulated by the MHRA, we have implemented independently audited quality and information security management systems.

We have also secured a number of certifications and accreditations to ensure we put patients first while delivering for our partners.

Regulatory

Class III CE approved
Class IIa UKCA approved
FDA Breakthrough Device Designation

Clinical safety

DCB 0129 compliant
ISO 14971 clinical risk management system
Post market surveillance – monitoring and ensuring we deliver our promise

Information security

ISO 27001 – certified
NHS DSP Toolkit – standards met
DTAC – documentation available upon request
GDPR -compliant
Cyber Essentials – certified

Quality systems

ISO 13485 – certified
CQC registered

Documentation is very thorough indeed (which is excellent), I only wish all companies would provide a detailed case to this level, hence thank you to Skin Analytics and the team.

Geoff Lavelle | Chief Clinical Informatics Officer & Clinical Safety Officer | Tameside & Glossop Integrated Care NHS Foundation Trust