Research and Regulation
At SkinVision, research is in the heart of our organization. By collaborating with leading academic medical centers and experts in the field of dermatology, we’re able to confirm the quality of its service and to further develop new capabilities.
With the growing implementation of SkinVision, we know our users, professionals, and partners expect high-quality research, publications and regulatory compliance as a strong fundament of the accuracy and efficacy of our service.
Retrospective Accuracy Study
mHealth Skin Cancer App Review
Eindhoven Clinical Validation Study
Munich Clinical Validation Study
SkinVision is currently regulated by the Directive 93/42/EEC of the European Union (EU), also known as the Medical Devices Directive – MDD. The CE marking is the medical device manufacturer’s claim that a product meets the essential requirements of the relevant European Medical Device legislation.
SkinVision implemented an ISO 13485:2016-compliant Quality Management System.
SkinVision implemented an Information Security Management System according to the internationally recognized standard ISO/IEC 27001:2013.
The SkinVision service is a software-only mobile medical application for over the counter (OTC) use. The application is intended to provide an immediate risk assessment for the most common types of skin cancer of a specific spot on the skin, based on an image taken by the user on a mobile device. Based on the assessment, the SkinVision service provides a recommendation on whether to visit a healthcare professional (HCP) for further review. The SkinVision service creates skin health awareness and allows the user to monitor spots on the skin over time and aid in discussions with healthcare professionals.
The SkinVision service is not intended to replace traditional methods of the evaluation of skin cancer risk level, is not a diagnosis, and is not a substitute for visits to a healthcare professional. The SkinVision service is not intended for people under the age of 18.