Achieving UKCA Class IIa certification for our DERM skin lesion analysis device is not just an important milestone in our company’s growth; it’s validation of the incredible work that our team has produced over the years. Whether it be artificial intelligence research, software development, clinical validation, user testing, or operational delivery, we’ve had a team of super talented people come together to build and deliver DERM for our partners and their patients.
Our AI device, DERM, uses machine learning algorithms to recognise the most common malignant, pre-malignant and benign skin lesions, including melanoma – the fifth most common cancer in the UK. Using a decade’s worth of research and development on skin lesions, it is designed to accelerate patient diagnosis and relieve pressure on the healthcare system.
Many will see the UKCA Class IIa certification process as the time taken between submitting an application to a UK Approved Body and the point at which certification is obtained. But it’s much more than that…
It starts with a Quality Management System (QMS); a collection of policies, processes and instructions that give us the framework around which to build high quality, reliable and safe medical devices. Integrated into this are state-of-the-art industry standards that guide critical activities such as risk management, software development and human factors engineering.
Using this framework, our multidisciplinary team has spent hours, weeks, months and years developing DERM to the level that instrustry standards, medical device regulations within the UK, and our customers demand of AI-based medical devices. These activities have included:
- Extensive artificial intelligence research, modelling, and training to develop highly sensitive and specific algorithms, tuned to the clinical needs of our patients.
- Rigorous software development practices to compile and deliver our AI models.
- Continuous risk management lifecycle activities, designed to ensure that any associated risks in the use of DERM are reduced as far as possible.
- Clinical validation studies, such as the world’s first prospective study for AI melanoma detection, to demonstrate the clinical safety and performance of DERM.
- Outstanding operational, training and technical support for our DERM clients.
- Developing robust post-market monitoring and surveillance systems that help ensure our device continues to operate to an exceptional level of safety and performance.
Frankly, this is just scratching the surface of what goes on behind the scenes here at Skin Analytics. Obtaining UKCA Class IIa certification is the celebratory bow wrapped around this work and recognition for the dedication required to bring the UK’s first Class IIa-certified AI dermatology device to market.
But it doesn’t stop there…we will continue to improve; continue to deliver better and more innovative products to our clients; and continue to adhere to the strictest level of regulatory controls whatever regulatory changes may occur in the future. I look forward to sharing many more announcements about our brilliant work – and our regulatory approvals – in the years to come.
If you have any questions or want to learn more about the Class IIa certification of DERM, please get in touch with me via firstname.lastname@example.org and I’ll be happy to help.
James Hamlyn, Quality & Regulatory Director