Skin Analytics is delighted to announce that we are now ISO 13485:2016 certified. ISO 13485:2016 is an internationally recognised quality standard for medical devices and is a pre-requisite for registration as a class II medical device under the MDR. This accreditation represents another important milestone for the company and our mission to help more people survive skin cancer.
In December 2019 the company underwent a rigorous 3 day audit of our Quality Management System, conducted by the British Standards Institution (BSI), to demonstrate that we not only have robust processes in place to meet regulatory requirements specific to the medical devices industry, but that we follow them in designing, building and operating our medical devices.
Our ISO 13485 certificate covers the design, development, production, deployment, and maintenance of software as a medical device to identify skin cancer. This award confirms our team’s dedication to delivering best in class solutions for patients through high quality medical products and services that are reliable, safe and compliant.
Martin Nwosu, Quality and Regulatory Manager at Skin Analytics commented:
“Quality is everyone’s responsibility and creating an effective Quality management system correlates with implementing a Quality culture within the organization. Over the last 12 months, Skin Analytics has embedded a quality culture within the organisation with all staff understanding the value an effective QMS adds to the business.I am proud that this Quality culture lead to BSI certifying the Skin Analytics Quality Management System to the ISO13485:2016 standard, but it is also reflected in the standard of products and services we provide”
Given our current focus of integrating our AI solution into health pathways within the NHS and insurance providers, our customers and partners can be confident that the systems and processes we have in place are managed to the highest standards.
Looking forwards, our focus at Skin Analytics will be to continue ensuring that we meet and exceed customer expectations and regulatory requirements. This accreditation is only one component of our broader regulatory activity, and supports our preparation activity for the Medical Device Directive (MDR) that will come into force on the 26th of May 2020.
To view our ISO 13485:2016 certificate on BSI’s website click here and search for Skin Analytics Ltd.