Learn the most up to date recommendations and best practices from the ISO 14971:2019 standard and how you can start to use risk management as a tool - not a checkbox activity.
The best QMS software comparison guide for medical device companies that will help you choose a quality management system solution that strategically benefits your product and company.
Know what questions to ask software vendors that give your medical device company the necessary information to consider when selecting a QMS software solution.
A definitive guide on change management best practices to help medical device companies understand and manage changes to documents, products, processes and more.
This free in-depth webinar will explore all regulatory pathways to market — including the lesser-known and lesser-used ones — to help you decide which to use when for your medical device.
A free in-depth webinar outlining a process that not only fits within the regulatory parameters, but also is so effective that it shortens the typical product development cycle leading up to your regulatory submission.
A free in-depth webinar covering the most important items that companies must understand and put into practice when developing and commercializing SaMDs.
A free in-depth webinar on industry benchmark survey findings of over 500 medical device professionals around the globe, covering the most compelling stats, biggest surprises, and must-know takeaways device makers need to know.
Episode 138
Evan Luxon
Co-founder & CEO, Centese
Chad McClennan
President, CEO, Koios Medical,
Graham Anderson
CFO, Koios Medical,
Patricia Setti-Laperch
Director of Regulatory Compliance and Quality, Koios Medical
Becky Fitzgerald
Principal/Co-founder, Two Harbors Consulting
"We wanted a QMS solution that was robust enough to grow with us, but simple enough to get us started."
“Greenlight Guru has been instrumental for us while we efficiently navigate the quality management system process and with developing our FDA submission.”
"I have a high degree of confidence that as changes to the regulations occur, I won't have to worry about being out of compliance because we are using Greenlight Guru."
"With Greenlight Guru, you've got software, but also what amounts to a personal consultant. Those connections are powerful."
By Jon Speer
MedTech Intelligence, March 6th, 2020
By Jon Speer
Medical Product Outsourcing, February 13th, 2020
