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Niki started the discussion Real-time AE Reporting in the forum IndieMedTech a year ago
I thought it was interesting that FDA will now report AEs real-time. I actually thought it was currently updated monthly, but looks like it was historically quarterly! https://www.fda.gov/news-events/press-announcements/fda-begins-real-time-reporting-adverse-event-data
fda.gov
FDA Begins Real-Time Reporting of Adverse Event Data
The U.S. Food and Drug Administration (FDA) today began publishing adverse event data on a daily basis, giving the public faster access to information on serious medication errors and product quality complaints for prescription drugs and therapeutic biologics.
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Holly replied to the discussion How to manage time with multiple clients? in the forum IndieMedTech a year ago
Reply to How to manage time with multiple clients?
Thanks Felicia! I was considering trying out Calendly – if anyone has experience with Calendly I would love to hear about it!
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Ashokkumar joined the group
indieFeed a year ago -
Kimberly joined the group
indieFeed a year ago -
Felicia replied to the discussion How to manage time with multiple clients? in the forum IndieMedTech a year ago
Reply to How to manage time with multiple clients?
Hey Holly! I’ve wrestled with this too. In the past I’ve used Outlook to juggle multiple inboxes and calendars, but it’s definitely not a perfect system…especially if you’re working off client-issued hardware and email, where consolidation isn’t always possible. In those cases, I’ve sometimes added my consulting email on calendar invites…
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Elizabeth joined the group
indieFeed a year ago-
Welcome Elizabeth! SO excited to see you on here!
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Holly started the discussion How to manage time with multiple clients? in the forum IndieMedTech a year ago
How to manage time with multiple clients?
Good morning indieMedTech family! I was looking for any tips and tricks on time management with multiple clients, multiple inboxes, etc. Thank you in advance!
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Nicholas joined the group
indieFeed a year ago-
Hi Nicholas! Welcome to indieMedTech!
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Holly replied to the discussion Medical device? in the forum IndieMedTech a year ago
Hi @AmieSmirthwaite I would definitely take a look at FDA’s guidance on general wellness devices (here’s the link: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-wellness-policy-low-risk-devices) to ensure that it truly meetings the definition of a general wellness product. There has been a lot of activity… Read more
fda.gov
General Wellness: Policy for Low Risk Devices - Guidance
This guidance provides clarity on FDA's compliance policy for low risk products that promote a healthy lifestyle (general wellness products).
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Amie started the discussion Medical device? in the forum IndieMedTech a year ago
This product was advertised to me on X/Twitter: http://www.humehealth.com – the health claims on X were pretty explicit (eg “early warning of health problems”). They seemed to have toned it down somewhat on their website, but I think some of these claims still put them into medical device territory in the EU… but I cannot see anything resembling a…
humehealth.com
Hume | Better Metabolic Health - Tap Into Your Body's Data
Reclaim your health by unlocking & understanding your body's data using powerful in-home health devices & our intuitive app. Make better choices through smart bio-hacking and AI powered insights
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