Skin Analytics’ DERM is the only 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.
National guidance & recommendations
- Recommended by the National Institute for Health and Care Excellence (NICE)
Regulatory
- Class III CE 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