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.
We'll take you through each section of 21 CFR Part 11, FDA's regulation for electronic documentation and electronic signatures. We'll explain what the requirements actually mean and expound the most important points for you to know as a medical device company.
In this free webinar participants will learn best practices for design validation, including how to avoid timely and costly validation mistakes and creative ways to use validation to their advantage!
A free webinar on the newly codified regulatory requirements for post-market surveillance (PMS) under the new Medical Device Regulations (MDR) that goes into effect May 2020, and how manufacturers can take a proactive role in their approach.
A free webinar about connecting empathy and purpose to gain meaningful user insights that translate into optimal design inputs and product quality in medical device development.
Project Manager, MR Coils
CEO, Spark Biomedical
Amir Fassihi, M.D.
Founder and CEO, Amnion Life
"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.”
“Greenlight Guru was essential for us to establish a strong foundation for success.”
By Jon Speer
Quality Digest, June 13th, 2019
By Evan Luxon, Centese (Greenlight Guru customer)
MedTech Intelligence, May 14th, 2019
By Jon Speer
ECN, March 25th, 2019