#396: Mastering Device Descriptions: The Cornerstone of Medical Device Submissions

#396: Mastering Device Descriptions: The Corn...

Greenlight Guru + Medical Device EntrepreneursGreenlight Guru + Medical Device Entrepreneurs

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#468: SaMD Issues, Defects & Detection | Shawnna Monterrey

Most discussions around medical device quality stop at commercial launch. Once a product ships, teams tend to celebrate and move on to the next development cycle. However, the real engineering work often begins the moment a device leaves the manufacturing floor. In this episode o ...  Show more

 . 44min 9sec
#467: Combination Product Compliance: PMOA, 21 CFR Part 4 & QMS Alignment

Navigating the regulatory landscape for combination products requires understanding how primary modes of action (PMOA) dictate oversight pathways. In this episode, host Etienne Nichols sits down with Jim Fentress, Director of Regulatory Affairs at Galero (a Santa Group company), ...  Show more

 . 35min 54sec

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