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

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).

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Some highlights of this episode include:

• What is SaMD? Software intended to be used for a medical purpose without being a part of the hardware of the medical device. 
• What isn’t SaMD? Hardware that doesn’t need to be updated to function, such as a pacemaker or other embedded medical devices. 
• IMDRF documents capture, evaluate, and monitor SaMD categories of classification for critical or non-critical functions. 
• EU MDR delay means big changes to classification rules for categories, specifically SaMD status and amount of evidence that needs to be collected.
• Three Key Components of Clinical Evaluation: 
  • Scientific Validity: Does software have a valid clinical association between software and targeted clinical condition?
  • Analytical Validation: Does software correctly process data the same way, every time? 
  • Clinical Validation: Does software accurately and reliably achieve the intended purpose for the target population?  
• 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.
• Importance of Independent Review(er): Objective outside party analyzes SaMD to make sure it’s safe and effective to use for critical decisions.
• Real World Evidence: Collect a broad dataset to better understand adverse events, conditions, and comorbidities that impact a medical device on society.

Related Resources:

Kevin Coker

Proxima Clinical Research 

Software as a Medical Device (SaMD)

European Medical Device Regulation (EU MDR)

International Medical Device Regulators Forum (IMDRF)

IMDRF SaMD Guidance Documents

The Greenlight Guru True Quality Virtual Summit

MedTech True Quality Stories Podcast

Greenlight Guru YouTube Channel

Greenlight Guru

Memorable Quotes by Kevin Coker:

“(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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