39 min
Season 2 - Episode 6: Electronic Quality Management Software with Jon Speer from Greenlight.Guru GuideWire
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- Ciencias de la vida
In this episode of GuideWire, Devin Hubbard with FastTraCS talks to Jon Speer, founder of Greenlight Guru and host of the Global Medical Device Podcast.
Jon discusses the origins of his company, electronic quality management software (QMS), and entrepreneurship experiences in the startup world.
Today’s Topics Include:
Greenlight Guru: Medical device success platform helps meet quality/regulatory needs
Greenlight Guru provides workflows to navigate/manage design/development process
Design Controls: Evidence demonstrates safe and effective products that actually work
Why electronic quality systems are easier to manage, maintain than paper-based ones
Primary Processes: Design controls, risk management, documentation, management
Quality system intent is to describe how business is conducted w/ regulatory compliance
Free Resources: How and where to learn about quality systems and regulatory affairs
Entrepreneurial Experiences: Got a good idea? Be patient, wait for conditions to be right
Guru: Story behind the business name, brand, and domain to be differentiator
Trends: COVID-19 created choice to grow and hire talent without relocating
Links and Resources:
Jon Speer on LinkedIn
Greenlight Guru
Greenlight Guru Podcasts
Greenlight Guru Medical Device Blog
Greenlight Guru YouTube Channel
Greenlight Guru - The Ultimate Guide to Design Controls
Greenlight Guru - Definitive Guide to ISO 14971:2019 Risk Management for Medical Devices
Greenlight Guru - ISO 13485: Ultimate Guide to the Quality Management System (QMS) for Medical Devices
U.S. Food and Drug Administration (FDA)
FDA - Guidance Document on Design Controls
FDA - Emergency Use Authorization (EUA)
HubSpot
Devin Hubbard
FastTraCS
FastTraCS Clinical Advisory Group
GuideWire Podcast on Twitter
GuideWire Podcast
Quotes/Tweets:
“Prior to Greenlight, there was no software solution designed specifically for the medical device industry.”
“My appro
In this episode of GuideWire, Devin Hubbard with FastTraCS talks to Jon Speer, founder of Greenlight Guru and host of the Global Medical Device Podcast.
Jon discusses the origins of his company, electronic quality management software (QMS), and entrepreneurship experiences in the startup world.
Today’s Topics Include:
Greenlight Guru: Medical device success platform helps meet quality/regulatory needs
Greenlight Guru provides workflows to navigate/manage design/development process
Design Controls: Evidence demonstrates safe and effective products that actually work
Why electronic quality systems are easier to manage, maintain than paper-based ones
Primary Processes: Design controls, risk management, documentation, management
Quality system intent is to describe how business is conducted w/ regulatory compliance
Free Resources: How and where to learn about quality systems and regulatory affairs
Entrepreneurial Experiences: Got a good idea? Be patient, wait for conditions to be right
Guru: Story behind the business name, brand, and domain to be differentiator
Trends: COVID-19 created choice to grow and hire talent without relocating
Links and Resources:
Jon Speer on LinkedIn
Greenlight Guru
Greenlight Guru Podcasts
Greenlight Guru Medical Device Blog
Greenlight Guru YouTube Channel
Greenlight Guru - The Ultimate Guide to Design Controls
Greenlight Guru - Definitive Guide to ISO 14971:2019 Risk Management for Medical Devices
Greenlight Guru - ISO 13485: Ultimate Guide to the Quality Management System (QMS) for Medical Devices
U.S. Food and Drug Administration (FDA)
FDA - Guidance Document on Design Controls
FDA - Emergency Use Authorization (EUA)
HubSpot
Devin Hubbard
FastTraCS
FastTraCS Clinical Advisory Group
GuideWire Podcast on Twitter
GuideWire Podcast
Quotes/Tweets:
“Prior to Greenlight, there was no software solution designed specifically for the medical device industry.”
“My appro
39 min