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Elizabeth joined the group
indieFeed 4 months ago2 Comments-
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 4 months 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 4 months ago-
Hi Nicholas! Welcome to indieMedTech!
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Holly replied to the discussion Medical device? in the forum IndieMedTech 4 months 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 4 months 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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Holly started the discussion Happy MedTech Monday! in the forum IndieMedTech 4 months ago
Happy MedTech Monday! Curious to know what everyone is working on this week in MedTech? I have some Notified Body responses, a regulatory strategy, and breakthrough designation request on my to-do list. Thank goodness for caffeine!
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Holly replied to the discussion Day 1 at IndieMedTech in the forum IndieMedTech 4 months ago
Reply to Day 1 at IndieMedTech
Who are you: Holly Cotter, Co-Founder indieMedTech, Principal Consultant at WLC
What’s your focus: bringing together MedTech professionals
What’s one thing you’re looking for in this community: Connecting to new people who I know share my love and passion for MedTech! -
Theresa replied to the discussion Day 1 at IndieMedTech in the forum IndieMedTech 4 months ago
Reply to Day 1 at IndieMedTech
Congratulations. This is an awesome tool!!
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Theresa joined the group
indieFeed 4 months ago -
Dongeun joined the group
indieFeed 4 months ago - Load More
