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 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.
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!
Principal/Co-founder, Two Harbors Consulting
Founder / CEO, PhotoniCare
Founder, Prodct LLC
"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 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.
By Jon Speer
Quality Digest, June 13th, 2019