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How can the IEC 62304 standard serve as a framework for your Software as a Medical Device (SaMD) development processes?

Today’s guest is Cathy Wilburn, Director of Quality Assurance and Compliance for The RND Group, a medical device software development company that helps clients write software, submission readiness, and compliance. Cathy joins Jon Speer to clarify the confusing parts of IEC 62304 and helps listeners understand how they can leverage this standard to improve development processes.

 

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Some of the highlights of the show include:

  • IEC 62304 is a software framework that offers necessary documentation and software engineering practices for 510(k) and PMA submissions to the FDA. 

  • Recognized Consensus Standard: FDA evaluated and recommends using IEC 62304 to satisfy regulatory requirements and software development needs.  

  • Requirement vs. Recommendation: IEC 62304 is voluntary, not prescriptive. However, most in the SaMD industry use and follow it to meet requirements.

  • IEC 62304 covers the following high-level software processes: Development, maintenance, risk and configuration management, and problem resolution. 

  • Lifecycle Processes: Examples and resources to blend waterfall, agile, scrum, and sprint methods for medical device software development and requirements. 

  • Design controls and history file contents are detailed or defined in FDA 21 CFR 820.30 and ISO 13485, but not part of the IEC 62304 Standard.  

  • ISO 14971: Risk management role in software development is defined in IEC 62304 via software safety classes for level of concern and risk requirements. 

  • Myth or Truth? SaMD requiring waterfall method is a rumor. The purpose is to iterate, learn, and refine to produce safe and effective products. 

 

Links:

The RND Group

IEC 62304

ISO/IEC 62304 Standard

Premarket Notification 510(k)

Premarket Approval (PMA)

FDA Recognized Consensus Standards

FDA Design Control Guidance

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

21 CFR 820.30

ISO 13485

ISO 14971

EU MDR

EU MDD

MedTech True Quality Stories Podcast

Greenlight Guru True Quality Roadshow

Greenlight Guru YouTube Channel

Greenlight Guru

 

Memorable Quotes by Cathy Wilburn:

“(IEC 62304) defines software lifecycle processes for medical device software. It’s recognized by the FDA as a consensus standard.”

“A consensus standard is something that’s developed by private sector. It’s not developed by the FDA, so it’s not a regulation.”

“It gives you the freedom to introduce it into your software development organization that you already have established.”


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