Skin Analytics’ DERM is the only UKCA approved Class IIa AI as a Medical Device for skin cancer

Skin Analytics’ DERM is the only UKCA approved Class IIa AI as a Medical Device for dermatology. 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 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

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