Does your software as a medical device (SaMD) function properly? Does it meet the needs of the end user? What are the expectations for post-market clinical surveillance and real world evidence for SaMD products in particular?
In this episode of the Global Medical Device Podcast Jon Speer talks to Kevin Coker, co-founder and CEO of Proxima Clinical Research. Kevin shares tips and advice on what companies need to know about clinical evaluation and validation for their Software as a Medical Device (SaMD).
“(SaMD) Software that’s intended to be used for a medical purpose that’s not part of the hardware of the medical device.”
“These are the (components) that are going to have to be done for my software system to ultimately have it blessed by any regulatory agency.”
“Clinical Validation: Does your software accurately and reliably achieve the intended purpose for the target population?”
“Collect a broader dataset to really understand the impact on society.”
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The Global Medical Device Podcast powered byGreenlight Guruis 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...