This is the essential guide to help you prepare your Quality Management System (QMS) for the new EU MDR before the transition period ends on May 26, 2020.
ISO 13485 - Ultimate Guide to the Quality Management System (QMS) for Medical Devices offers industry professionals everything related to the topic. Greenlight Guru eQMS platform automates regulatory compliance with ISO 13485:2016, FDA, ISO 14971, so companies can focus on true quality of devices.
This eBook provides 15 reasons you need a solution such as Greenlight Guru that provides built-in compliance, provides traceability, takes little time to implement, and is augmented by experts with more than a decade in the medical device industry.
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.
In this free webinar participants will learn how to apply Risk Management (Risk Analysis, Risk Evaluation, Risk Control, Overall Residual Risk Evaluation, Production and Post Production Monitoring) to a medical device as it moves throughout the stages of the Product Lifecycle (Concept, Development, Launch, Post Market, Obsolescence).
In this free webinar participants will learn about the key steps to take when preparing a 510(k) Premarket Notification and how to avoid common pitfalls that can occur during this process.
President, CEO, Koios Medical,
CFO, Koios Medical,
Director of Regulatory Compliance and Quality, Koios Medical
Principal/Co-founder, Two Harbors Consulting
Founder / CEO, PhotoniCare
“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."
"I highly recommend Greenlight Guru. They have taken a complex industry and made it into a product that’s simple to use.”
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.
By Evan Luxon, Centese (Greenlight Guru customer), Medical Product Outsourcing, June 24th, 2019.
As an early-stage medical device company, it may seem simpler to implement a paper-based QMS than to choose from the thousands of QMS software providers out there. Better yet, you're saving money by choosing the paper-based route, right? Wrong.
By David Deram, Forbes, June 13th, 2019.
Quality is manifested by the level of commitment that’s invested. Quality outcomes don’t happen by chance; they are carefully crafted to deliver a memorable experience to the end user. This mindset is at the core of Greenlight Guru and serves as the heartbeat of the company.