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.
Learn how to manage all the changes to your medical device QMS to comply with the new regulations & standards; EU MDR, EU IVDR & ISO 13485:2016.
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.
A free webinar on the ways in which UX design can mitigate human error while reducing both recalls and product development costs.
A free webinar on the simple ways you and your team can learn to integrate documentation best practices so you can mitigate risk and systemic issues.
A free webinar on the critical steps that are needed in order to prepare your Quality Management System (QMS) for the upcoming EU Medical Device Regulations (EU MDR) in 2020.
"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.”