SkinVision, the leading app for early detection of skin cancer, recently achieved three important ISO certifications. The British Standards Institution (BSI Group), 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, which includes additional requirements to ISO 27001, specifically for healthcare providers in the Netherland, where SkinVision is based.
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 helping individuals manage their skin health.
SkinVision’s recent regulatory development is also in preparation for the new Medical Device Regulation (MDR) coming to application in Europe in May 2020.
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 to our customers.”