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Recorded Webinar
FDA Guidelines for IoT (Internet of Things) Wireless Medical Devices
timelapse 60 mins with 10-15 mins of Q and A
Note:
This webinar occured in the past
Along with recorded webinar, copy of presentation slides will be shared
Recorded Webinar can be played unlimited times
Speaker/Presenter
Short Abstract
The biggest trends changing medicine across the entire value chain from research to healthcare delivery are wireless enabled medical devices frictionless streaming patient data from everywhere, all the time. Wearables not under FDA regulation will be briefly mentioned; but the emphasis of the webinar will be on wireless medical device compliance requirements that include:
- Class I devices: 21 CFR Part 807 and 812, QS, Labeling, and IDE
- Class II devices general controls
- Class III and premarket approval 21 CFR Part 814
Will provide best practice case studies on how best to approach the FDA for a novel approach on the use of wireless medical device and sensors:
- Standards to keep in mind from Critical Path Institute, HL7 and the International mHealth Standards Consortium
- Live case studies currently operating and what we have learned in terms of pitfall and opportunities
- Forecast projection growth into the Internet of Things (IoT) from todays numbers and into 2022
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