Holly
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Jeff and
Holly are now connected 3 days ago -
Hi everyone! FutureReady: MedTech Live is back with Episode 04: QMSR – The Eleventh Hour. Join us, along with an esteemed panel, on Thursday, January 29 at 4 pm EST to discuss everything QMSR and what you can do now to be (more) ready on February 2.
Register here: …
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Reply to New FDA Guidance Documents
Thank you! The general consensus seems that its incredibly de-regulating. Normally I think we would all applause at that but it may sway into a potentially dangerous zone. Will be interesting to see how some key players respond next.
For anyone working with wellness or borderline wellness devices, what’s your next step? I have one so now I…
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Holly joined the group
3 weeks agoCodon Partners Career Corner 3 weeks ago -
Happy Wednesday! You may have noticed a new tab at the top – the Library! A curated collection of MedTech content created by our members, for our members. We quietly launched this new page and are now ready to celebrate it. Currently, all episodes of FutureReady: MedTech Live can be found there.
Do you have or want to create MedTech content…
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FDA dropped two new guidance documents today:
- General Wellness: Policy for Low Risk Devices – https://www.fda.gov/media/90652/download
- Clinical Decision Support Software – https://www.fda.gov/media/109618/download
I haven’t had a chance to dig in yet, but has anyone else? Any significant clarifications or advancements that may tangibly help…
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Holly and
Catherine are now connected 6 weeks ago -
Hi everyone, I have a client where I am trying to decide whether to recommend a BDDR or a pre-submission first. They will need another pre-submission eventually as their submission requires a GLP animal study and potentially another clinical study (and in their last pre-sub the FDA asked them to present their substantial equivalence table so…
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Reply to Comparison Table for eQMS Packages
Thanks this is wonderful! I would be interested to see how @quickvault-by-veeva compares?
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Does anyone know why we can no longer see 510k summaries in the 510k database? I am even trying old ones that I know I have pulled recently and they are all missing…
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I swear I looked at some this morning and now they are not there. Any updates?
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Not definitively – based on a some folks I have talked to we think its just maintenance things? Fingers crossed – if this was intentional I would hope they would release something about it.
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