I'd like to start a thread to discuss challenges associated with incorporating mobile devices into medical devices.
There are several applications:
Unfortunately, despite huge potential in this area (as mobile devices become ubiquitous), it's difficult to plan out a development project without a clear sense of the regulatory expectations. Any input, or links to guidances/regulations dealing with these concern much appreciated!
There are several applications:
- Mobile device is intended to replace an existing wireless controller. This was discussed briefly in another thread.
- Mobile device used to configure a medical device (but not involved in actual therapeutic use).
- Mobile device used to passively gather data from the medical device.
- What level of evidence is expected to make such a generalized statement? Surely not all permutations of operating system versions and hardware is required to be tested? Is there some guidance as to the appropriate level of testing?
- How do you deal with EMC safety? In particular with respect to case (1) above - the mobile device, acting as a controller, is essentially part of the medical device. Again, surely the expectation is not that you've 60601-1-2 tested every compatible mobile device?
Unfortunately, despite huge potential in this area (as mobile devices become ubiquitous), it's difficult to plan out a development project without a clear sense of the regulatory expectations. Any input, or links to guidances/regulations dealing with these concern much appreciated!