SkinVision, the leading app for early skin cancer detection, recently achieved three important ISO certifications. The British Standards Institution (BSI), awarded SkinVision ISO 13485:2016 for its quality management system. Additionally, BSI awarded the company ISO 27001:2013 for information security management, as well as the Dutch national standard NEN 7510:2017, which includes additional requirements to ISO 27001:2013, specifically for healthcare providers in the Netherlands, where SkinVision is based.
SkinVision is expanding its reach by partnering with health insurers to offer the masses the chance to use the service through reimbursable healthcare. The NEN 7510 certification strengthens existing partnerships with Dutch health insurers including CZ, Just, and Nationale-Nederlanden.
SkinVision’s recent regulatory development is also in preparation for the new Medical Device Regulation (MDR) coming to application in Europe in May 2020. The dedication from the team helped to shape an integral process for managing the company’s information security and quality systems as part of the ongoing commitment to providing a safe, secure and trustworthy service.
Breght Boschker, CTO of SkinVision said, “We are incredibly proud of these achievements, which involved and brought out the best in the whole SkinVision team. SkinVision is committed to delivering a world-class safe and effective, compliant medical device. These certifications mean the next step for SkinVision as an organization to show how serious we are in our mission to save 250.000 lives. Our users’ safety and security are key, and we want to take every step to provide the highest levels of quality and regulatory compliance.”
SkinVision was founded in 2012 and is an awareness and tracking solution that supports individuals with the early recognition of the most common forms of skin cancer (melanoma, squamous cell carcinoma, basal cell carcinoma, and precancerous actinic keratosis). SkinVision is the first certified skin cancer application based on extensive clinical trials, conducted in partnership with Erasmus Medical Center (EMC) and the university clinic of Ludwig Maximilian University (LMU). In the most recent study, published in the Journal of the European Academy of Dermatology and Venereology (JEADV), researchers determined the app has a sensitivity of 95% and specificity of 78%.
The company has built up a customer portfolio of 1.2 million users globally and a database of 3.5 million pictures of suspicious and benign skin lesions. The SkinVision app is commercially available worldwide on iOS and Android except for the United States and Canada. SkinVision is headquartered in Amsterdam, the Netherlands.