Regulations
What percentage of 510(k) submissions are rejected the first time through?
69%
What does MDSP stand for?
Medical Device Success Platform
What year was Greenlight Guru founded?
2013
How many customers do we have?
> 550
Asking this type of question feels more conversational and less like an interrogation
Open-ended
The FDA approves products for sale in the US - what is the EU equivalence of the FDA?
Notified Body
Name the 5 pillars of a MDSP
1. Product Dev 2. Quality 3. Regulatory 4. Intelligence 5. Guru Edge
What are the three software packages Greenlight Guru offers?
Essentials, Plus, Professional
List 5 Customers you can name drop on a call
Any 5 are acceptable
Name the four personas we sell to (as defined in the sales playbook)
1. Product Development 2. QA/RA - Inexperienced 3. QA/RA - Experienced 4. Executive
What is the MDSAP program and what countries does it include?
Australia, Brazil, Canada, Japan and the United States.
How does MDSP differ from eQMS?
Variety of responses are acceptable
What were the last three major product releases by Greenlight Guru (not including MFA/project cloning)?
1. Visualize 2. Training 3. Halo for Change
How much funding did Greenlight Guru secure this year and which firm made the growth equity investment?
JMI Equity Partners - $120M
What are the 4 Ps and the 3 Ws?
1. Professional 2. Polite, 3. Person 4. Provocative
1. Who 2. What 3. When
How many internal audits should be conducted per year?
This is defined by the company - trick question!
As a part of the Guru Edge, we offer a QMS template package. How many documents are included in that package and what are they comprised of?
74 documents comprised of procedures, forms, and templates, work instructions.
Name the Greenlight Guru Mission, Vision and Values
Mission: Improve the Quality of Life
Vision: Be the #1 MDSP in the world
Values: Provide Fanatical Support, Be Innovative, Culture of Closing, True Quality
Tell me the story of a SaMD company we've helped... the name, their location, pain points and why they selected GG
Any is acceptable
We don't discount, we trade (as outlined by Todd Caponi). What are our four contract levers?
Volume, Timing of Signature, Timing of Cash, Contract Length
As it pertains to labeling, describe Intended Use vs Indications for Use
Intended = device
Indication = patient
Which QMS process allows you to bypass an investigation?
Complaint Handling
Name the 8 Gurus we have on staff
Jesseca Lyons, Tom Rish, Taylor Brown, Wade Schroeder, Sara Adams, Etienne Nichols, Laura Court, Ryan Behringer
Tell me the story of an IVD company we've helped... the name, their location, pain points and why they selected GG
Any is acceptable
Identify the Four Buying Influences and explain their roles (Strategic Selling)
1. Economic Buyer 2. User Buyer 3. Technical Buyer 4. Coach