ISS AG developed on behalf of eHealth Suisse a manual and checklists for the development of secure health apps.
Software engineers have to ask themselves very early in the process of developing a health app, if their product falls into the category of a medical device and which regulation they have to adhere with. The manual supports the software engineers in this process. It provides practical assistance for the distinction between Lifestyle / Wellness products and medical devices as well as for the preparation of the certification process as medical device.
The guide is accompanied by Checklists, which guides the developer through relevant issues to achieve the development of a secure and compliant medical device.