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Why is verification and validation (V&V) confusing and challenging for many medical device professionals?

In today’s new episode of the Global Medical Device Podcast, Jon Speer and his guest Brad Graves, Principal Project Manager at The RND Group explore key aspects of the verification and validation topic and provide helpful clarification to medical device professionals about V&V cloud-based software.

 

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Some of the highlights of the show include:

  • Verification demonstrates that you designed the product correctly. Validation confirms you designed the correct product.

  • V&V are distinct, but interrelated activities. For example, a product can pass verification, but fail validation. Also, verification can be a product’s validation.

  • V&V Protocols, Approaches, and Tools: Involve product definition, requirements, risks, application and operating systems, and test cases.  

  • Does all software require validation? Medical device software must be verified and validated, but software that supports medical devices may only require verification or validation.  

  • Advantages and Disadvantages: Cloud software is easy to install, highly portable and scalable, but allocation of servers and additional IT staff are not necessary.

  • How can rules and regulations for computer and software validation be managed? Cloud changes are out of your control, but guidance is available on how to make or isolate changes via structures, architectures, and containers. 

 

Links:

The RND Group

Global Medical Device Podcast Episode 137: How to Leverage IEC 62304 to Improve SaMD Development Processes

FDA - Medical Devices

IEC 62304

AAMI TIR45: Guidance On The Use Of Agile Practices In The Development Of Medical Device Software

ISO 13485

ISO 14971

EU MDR

Docker

MedTech True Quality Stories Podcast

Greenlight Guru True Quality Roadshow

Greenlight Guru YouTube Channel

Greenlight Guru

 

Memorable Quotes by Brad Graves:

“Verification is testing that a software product meets its specifications; basically, its written requirements.”

“Validation is confirming that the overall product—hardware, software, or software as a medical device—meets its intended use.”

“To run tests and work backwards is not very efficient and runs the risk of not tracing appropriately, not testing adequately, not doing adequate risk assessments.”


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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.

Like this episode? Subscribe today on iTunes or SoundCloud.