Fitness software for phones, watches and other wearable devices is common. So when does software cross a line and need to comply with medical device legislation?
Medical devices used for health purposes are regulated and must meet certain standards or approvals depending on a risk profile. In Canada medical devices are rated from class 1 through 4, class 4 requiring the most scrutiny.
Health Canada recently published draft guidelines on when software has a medical purpose that requires it to follow the medical device standards.
Software intended for maintaining or encouraging a healthy lifestyle, such as general wellness . . . [more]