The Clinical Problem Solvers

SEPTEMBER 30, 2020

Blog post – by Smitha Download CPSolvers App here Patreon website Melanie Fellay Melanie Fellay is the CEO and Co-Founder of Spekit, the leading in-app learning and digital enablement companion that helps employees learn their tools and navigate process changes by accessing training resources in real-time, everywhere they work.

Specialization 52

Specialization Finance Engineering Diagnosis 52

FDA Law Blog

FEBRUARY 19, 2024

Loloei also served as a Senior Policy Advisor in CDRH and as a Special Advisor in the Office of the Commissioner. Loloei graduated magna cum laude , with a degree in Biomedical Engineering with a concentration in Electrical Engineering from The George Washington University. While at FDA, Ms. During her FDA tenure, Ms.

Engineering 59

Engineering Manufacturing Specialization Management 59

FDA Law Blog

NOVEMBER 5, 2023

Won will share his expertise and insights on the intricacies of the United States Food and Drug Administration (FDA) regulations pertaining to medical devices, with a special focus on class II and class III hearing devices.

Engineering 52

Engineering Specialization Community Medical 52

FDA Law Blog

JULY 10, 2023

In this blog post, we will first briefly outline the procedural steps in the 510(k) review process for medical devices. Understanding the Traditional 510(k) Review Timeline There are three types of Premarket Notification 510(k)s: Traditional , Special , and Abbreviated. an administrative appeal) under 21 CFR 10.75

Provider 75

Provider IT Engineering Medical 75

FDA Law Blog

FEBRUARY 22, 2023

In 2016 , the agency issued its definitive HF guidance, guide manufacturers through human factors engineering processes during the development of new medical devices, focusing specifically on the user interface. as a de novo special control or in a guidance document for a specific device type).

Manufacturing 64

Manufacturing Engineering Medical IT 64

New South Family Medicine and MedSpa

NOVEMBER 24, 2022

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Family Medicine 40

Family Medicine DO Family Families 40

New South Family Medicine and MedSpa

SEPTEMBER 17, 2019

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Referral 40

Referral Family Medicine DO Primary Care 40