In this modern digital world, did you know that most medical devices are not connected to the internet?

This episode of the Global Medical Device Podcast is a special live recording of The Greenlight Guru True Quality Roadshow in San Jose, California and moderated by Tom Rish, Medical Device Guru at Greenlight Guru. Chris DuPont, CEO of Galen Data, joins Tom as his guest to discuss the design review, development and risk process for software as a medical device (SaMD) with live viewers and podcast listeners.

Some highlights of the show include:

– Galen Data's goal: Configurable, scalable, FDA-compliant software platform that easily and cost-effectively connects medical devices to an FDA-compliant cloud.
– Check Engine Equivalent: Galen Data's enabling staging platform for predictive analytics data and early integration into electronic medical records (EMR).
– Input vs. output: design and risk management for mechanical/hardware or software as a medical device are the same.
– Design review and development process: identify requirements, build prototypes and test the design. Options include waterfall, agile, scrum, or sprint methods.
– What is the difference between verification and validation testing? Verifying a specification is easy, validating it is difficult due to user requirements and actual usage.
– Regulatory Pathway: Documents and prototypes allow software designers to use tools that help produce objective evidence and create a better product.
– Design History File (DHF) and Standard Operating Procedure (SOP): document what you do and do what you document. Follow your procedures.
– SaMD risk analysis: classification (I, II and III) and categorization of objects and components as low, medium and high software risks.

RELATED RESOURCES:
https://www.greenlight.guru/events/true-quality-roadshow
https://www.galendata.com/
https://www.greenlight.guru/blog/software-requirements-product-development
https://www.fda.gov/medical-devices/digital-health/software-medical-device-samd
https://www.greenlight.guru/blog/design-controls
https://www.iso.org/iso-13485-medical-devices.html
https://www.fda.gov/about-fda/economic-impact-analyses-fda-regulations/medical-device-de-novo-classification-process-proposed-rule-regulatory-impact-analysis
https://github.com/
https://www.atlassian.com/software/jira
https://aws.amazon.com/
https://www.greenlight.guru/blog/author/tom-rish/
https://www.greenlight.guru/
https://www.greenlight.guru/podcast-mtqs/

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