{"href":"http://player.captivate.fm/services/oembed?url=http%3A%2F%2Fplayer.captivate.fm%2Fepisode%2F2dce8b28-ed72-4b93-92b7-a049ce194149","version":"1.0","provider_name":"Captivate.FM","provider_url":"https://www.captivate.fm","width":600,"height":200,"type":"rich","html":"","title":"What you Need to Know about Clinical Evaluation & Validation for Software as a Medical Device (SaMD)","description":"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?\n\nIn 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).\n\nSome of the highlights of the show include:\n \n- What IS SaMD? Software intended to be used for a medical purpose without being a part of the hardware of the medical device. \n- What ISN'T SaMD? Hardware that doesn\u2019t need to be updated to function, such as a pacemaker or other embedded medical devices. \n- IMDRF documents capture, evaluate, and monitor SaMD categories of classification for critical or non-critical functions. \n- EU MDR delay means big changes to classification rules for categories, specifically SaMD status and amount of evidence that needs to be collected.\n- Three Key Components of Clinical Evaluation: \n - Scientific Validity: Does software have a valid clinical association between software and targeted clinical condition?\n - Analytical Validation: Does software correctly process data the same way, every time? \n - Clinical Validation: Does software accurately and reliably achieve the intended purpose for the target population? \n- Clinical Evaluation vs. Clinical Trial: Gather existing data for the same or similar intended use. A clinical trial is not always necessary to generate and justify evidence.\n- Importance of Independent Review(er): Objective outside party analyzes SaMD to make sure it\u2019s safe and effective to use for critical decisions.\n- Real World Evidence: Collect a broad dataset to better understand adverse events, conditions, and comorbidities that impact a medical device on society.","thumbnail_width":300,"thumbnail_height":300,"thumbnail_url":"https://artwork.captivate.fm/25e9ab65-2587-4dc2-9110-6f2980483f0a/c7a611ac-384c-4176-928e-95a4048e9819.jpg"}