Holly
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Theresa and
Holly are now connected 7 months ago -
Michelle and
Holly are now connected 7 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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Holly and
Amie are now connected 7 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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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! -
Holly and
Melissa are now connected 7 months ago -
Holly changed their profile photo 7 months ago
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Holly updated their profile 7 months ago
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The doors to indieMedTech are officially open, and you’re in on Day 1!
This is where MedTech professionals can swap stories, trade tips, and help each other solve those “hmm… how do I handle this?” moments.
Think of it like your virtual coffee shop for all things MedTech — only the Wi-Fi never drops and everyone gets what you’re talking…
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