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
Laurie Reed
Nov 18, 20247 min read
Takeaways from the MassMEDIC Regulatory Roundup Review
Check out Laurie's take-aways from the MassMEDIC Regulatory Roundup Review. A must-read on latest topics for medical device development.
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Laurie Reed
Sep 11, 20245 min read
FDA Draft Guidance on Predetermined Change Control Plans: Implications for Medical Device Manufacturers
Read about the FDA's new guidance, which details how medical device manufacturers can include pre-planned modifications in their submission.
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Beth Loring
Jun 27, 20235 min read
FDA Guidance on the Q-Submission Program
Check out LHF's analysis of the new FDA guidance on the Q-Submission Program! A must-read for anyone interested in interacting with the FDA!
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Beth Loring
Apr 6, 20232 min read
FYI, Most Medical Devices Are Not Designed For Most People
Read about Beth Loring's and Elizabeth Johansen's work on applying human factors engineering methods to design for under-resourced settings.
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Beth Loring
Dec 14, 20214 min read
Summary of MedTech Intelligence’s Webinar from Nov 30th, 2021
I recently attended a webinar hosted by MedTech Intelligence called “EU MDR Lessons Learned.” The webinar content was presented by three...
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Beth Loring
Jun 2, 20214 min read
Telehealth During and After Covid-19
Rise in Telehealth during Covid 19 In the last year and a half, state-mandated travel and operating capacity restrictions have caused a...
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Beth Loring
Sep 28, 20202 min read
4 Examples of How COVID is Accelerating Home Use Devices
At the beginning of September 2020 I attended the online forum “Digital Health and COVID-19: How COVID is Accelerating Home Use Devices”...
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Beth Loring
Apr 24, 20193 min read
Updates from the FDA CDRH Human Factors Team 2019
A few interesting things I learned from the FDA HFPMET at this year's HFES healthcare symposium.
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Beth Loring
Mar 17, 20173 min read
FDA/CDER Workshop Highlights
Last week I attended the sixth annual HFES International Symposium on Human Factors and Ergonomics in Health Care in New Orleans, LA,...
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