First time I'm posting on behalf of a friend, who is developing a unique wearable device with features not unlike the recent de novo and 510(k) class II clearances by Apple, Fitbit, and BioIntelliSense.
They may need a regulatory consultant, favorably in the midwest, who has experience with the regulatory classification of a wearable device and, if required, handling the submission. The device incorporates AI-type software, secure integration to cloud/IoT, and the intended uses are safety-related functions such as location/geo-fencing alerts, vital signs, fall detection, SOS/911, etc., with potential application in both pediatric and adult populations. If you or someone you know have a regulatory background or experience in this field, please contact me.
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Roger Cepeda, JD, MBA, RAC
MedTech Law LLC
roger@medtech.lawMobile: 847-421-8361
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