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What if we dont recommend treatment...more so utilizing the analytics they dont track. We wouldn't recommend, every case is different. That is between the user
by yatoomy 12y ago
What if we dont recommend treatment...more so utilizing the analytics they dont track. We wouldn't recommend, every case is different. That is between the user and their medical professional
- mcmancini 12y agoI would guess that collecting data in this case could still fall under regulatory preview, and that you would also need to qualify your sensors (Pebble) too. It really would be best to speak to someone familiar with Canadian medical device data. Much cheaper to do things right from the start (e.g., develop under IEC 62304) than to fix things later after getting a nasty gram from the Canadian FDA equivalent. Maybe through very careful marketing you can work around potential problems, or maybe not. I think that this project is in an area that requires an expert opinion, however.