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Do We Need a User Manual for Our Software as a Medical Device?
Anonymous
updated about 1 year ago
We’re developing a mobile app which will be a medical device. We’re wondering whether we have to provide a user manual for it, keeping in mind that most (non - medical device) apps on the market don’t
Accepted answer
Our recommended strategy for MDR class I and IIa would be this: • Have an electronic user manual which is accessible in your app by e.g. linking to