Greenlight Guru's State of Medical Device Product Development and Quality Management 2020 Report is here.
A definitive guide on change management best practices to help medical device companies understand and manage changes to documents, products, processes and more.
In-depth guide covering the new EU MDR General Safety and Performance Requirements (GSPRs) that must be implemented under EU Medical Device Regulation (MDR 2017/745).
A guide to the top 5 recommended best practices that medical device companies should consider when choosing a quality management system (QMS) solution.
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.
A free webinar covering the design control “framework” and recommendations to effectively meet their requirements. Emphasis will be placed not only on regulatory aspects but on effective design strategy, which is very important to avoid spending unnecessary time and money on an ineffective design control process.
A free webinar on how you can establish an effective medical device change control process to ensure internal consistency throughout your quality management systems and documentation.
A free webinar covering the new changes to ISO 14971:2019, the medical device risk management standard and its companion guidance document, ISO TR 24971:2019, that will be published by year-end.
Episode 130
Episode 129
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."
.jpg?height=100&name=Medical-Design-and-Outsourcing-Logo%20(1).jpg)
By Jon Speer
Medical Design & Outsourcing, January 16th, 2020
By Jon Speer
Medical Product Outsourcing, January 15th, 2020
By Jon Speer
MedTech Intelligence, December 27th, 2019
