Classification, qualification, and other changes to Software as a Medical Device (SaMD) under the new European Medical Device Regulation (EU MDR) continue to create angst and uncertainty.
In this episode, Andrew Wu and I discuss the ramifications of these changes. Andrew is a software consultant with Rook Quality Systems and software as a medical device (SaMD) expert.
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How do startups leverage FDA’s Pre-Cert Working Model - Part 1
How do startups leverage FDA’s Pre-Cert Working Model - Part 2
What are the Regulatory Expectations for Software as a Medical Device (SAMD)?
Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
European Medical Device Regulation (EU MDR)
Digital Health Software Precertification Program
International Medical Device Regulators Forum
Online database of medical devices
Ultimate Guide to Software as a Medical Device (SaMD)
MedTech True Quality Stories Podcast
“This is going to be a big deal, if you’re not prepared for it.” Jon Speer
“The last thing you want to happen is have your device be unavailable on the market.” Andrew Wu
“Back in the MDD days, there was no provision that was specifically for software.” Andrew Wu
The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.
Nick Tippmann is the Chief Marketing Officer for Greenlight Guru, a MedTech Lifecycle Excellence Platform (MLE) that provides an industry-specific solution to help medical technology innovators around the world use quality as an accelerator to move beyond baseline compliance and achieve True Quality. Tippmann is...