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 complete guide for medical device manufacturers looking for guidance on how to plan for a successful product launch and maintain regulatory compliance across global markets.
In-depth overview of Agile design and development processes to improve risk and quality management of medical devices that fulfill user and business needs.
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.
In this free webinar participants will learn post-market surveillance best practices
for medical devices and combination products to avoid timely and costly mistakes, as well as creative ways to use post-market surveillance to their advantage!
In this free webinar participants will learn how and when to start formal design controls to improve product development through an innovative and proven approach known as DHF Ready Ideation.
In this free webinar participants will learn how and when to register EU medical devices and report Unique Device Identification (UDI) information to EUDAMED, manage UDI submission data, and prepare for expected future challenges with UDI once EU MDR goes into effect.
Episode 123
Episode 122
Episode 121
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."
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By Jon Speer
Medical Design & Outsourcing, October 30th, 2019
By Jon Speer
Quality Digest, October 22nd, 2019
By Jon Speer
The MedTech Conference , August 26th, 2019
How prepared is your quality management system for the new requirements of EU MDR for medical devices that will go into effect in less than a year? Learn what you need to do to prepare with this comprehensive guide.
