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Description

Have you ever wondered, what does a medical device guru actually do? What role do they play within Greenlight Guru and what value do they bring medical device companies in the context of the QMS software?

In this episode of the Global Medical Device Podcast, Jon Speer talks to Tom Rish, a senior medical device guru and manager of the guru team at Greenlight Guru.

Tom shares his unique insights into the life of a medical device guru at Greenlight Guru, how the guru team engages with customers beyond the software itself, and how the "Guru Edge" has come to be one of Greenlight Guru's most valuable offerings to medical device companies around the world.

Some highlights of this episode include:

Memorable quotes by Tom Rish:

“Greenlight Guru is more of an experience and not just buying software. We feel like the gurus are a big part of that experience and we want to make sure that we hold up our end of the bargain to that.”

“We found early that our customers are coming to us with a lot of different questions.”

“It’s very humbling and also encouraging to see how many people out there are just really passionate about their ideas.”

“You can do a lot of work to get your product ready to launch knowing that you can add stuff on later.”

Links:

Tom Rish

FDA - Medical Devices

FDA - Guidance Documents

510(k) Submission Process

FDA Inspections and ISO Audits: What is the difference?

Software as a Medical Device (SaMD)

European Union Medical Device Regulation (EU MDR)

In Vitro Diagnostics Regulation (IVDR)

Global Medical Device Podcast, Episode 177: 5 Actionable Lessons Learned from the RADx Initiative by NIH 

Global Medical Device Podcast, Episode 205: Global Medical - Things I wish I knew as FDA reviewer

Global  Medical Device Podcast, Episode 158: Meet a Guru - Tom Rish

Global Medical Device Podcast, Episode 155: Meet a Guru - Jesseca Lyons

Global Medical Device Podcast, Episode 153: Meet a Guru - Taylor Brown

Global Medical Device Podcast, Episode 160: Meet a Guru - Wade Schroeder

Global Medical Device Podcast, Episode 188: Meet a Guru - Sara Adams

Global Medical Device Podcast, Episode 206: Meet a Guru - Laura Court

Global Medical Device Podcast, Episode 207: Meet a Guru - Etienne Nichols

Greenlight Guru Academy

The Greenlight Guru True Quality Virtual Summit

Greenlight Guru YouTube Channel

MedTech True Quality Stories Podcast

Greenlight Guru