# What you Need to Know about Clinical Evaluation & Validation for Software as a Medical Device (SaMD)

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2020-05-20
- Length: 36m
- Episode: 147
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-05-20-what-you-need-to-know-about-clinical-evaluation-validation-for-software-as-a-med
- Listen: https://podcast.greenlight.guru/episode/what-you-need-to-know-about-clinical-evaluation-validation-for-software-as-a-medical-device-samd

## Summary

Kevin Coker, co-founder and CEO of Proxima Clinical Research, explains the clinical evaluation and validation requirements for Software as a Medical Device (SaMD). He details the three pillars of clinical evaluation—scientific, analytical, and clinical validity—and discusses how IMDRF categories determine the need for independent review. The conversation covers strategies for generating evidence, including the use of real-world evidence and post-market surveillance to satisfy FDA requirements without always requiring prospective clinical trials.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-05-20-what-you-need-to-know-about-clinical-evaluation-validation-for-software-as-a-med#t=0) Introduction: Jon Speer and Kevin Coker on SaMD
- [3:39](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-05-20-what-you-need-to-know-about-clinical-evaluation-validation-for-software-as-a-med#t=219) Defining Software as a Medical Device (SaMD) and Non-SaMD
- [6:32](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-05-20-what-you-need-to-know-about-clinical-evaluation-validation-for-software-as-a-med#t=392) IMDRF Classification Categories and Independent Review Requirements
- [14:27](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-05-20-what-you-need-to-know-about-clinical-evaluation-validation-for-software-as-a-med#t=867) The Three Components of Clinical Evaluation: Scientific, Analytical, and Clinical Validity
- [22:51](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-05-20-what-you-need-to-know-about-clinical-evaluation-validation-for-software-as-a-med#t=1371) Generating Clinical Evidence and Managing Data Sets
- [25:53](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-05-20-what-you-need-to-know-about-clinical-evaluation-validation-for-software-as-a-med#t=1553) The Role of Independent Reviewers in High-Risk Software
- [29:23](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-05-20-what-you-need-to-know-about-clinical-evaluation-validation-for-software-as-a-med#t=1763) Real-World Evidence and Post-Market Surveillance Strategies

## Topics

- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)

## Most relevant to

early-stage companies

## Mentioned

- Proxima Clinical Research (company)
- Greenlight Guru (company)
- IMDRF (other)
- FDA (other)
- EU MDR (other)
- Zantac (product)

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## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-05-20-what-you-need-to-know-about-clinical-evaluation-validation-for-software-as-a-med. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Global Medical Device Podcast.