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