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.
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.
Free webinar series presented by FDA Case for Quality Manager Cisco Vincenty in partnership with Greenlight Guru. This four-part webinar series covers the future of FDA's Case for Quality initiative and its benefits to the medical device industry.
Free webinar series presented by FDA Case for Quality Manager Cisco Vincenty in partnership with Greenlight Guru. This four-part webinar series covers the future of FDA's Case for Quality initiative and its benefits to the medical device industry.
Episode 84
"I was actually a little nervous going into the audit, because it seemed too effortless."
“Not having your Design control or Risk Management can be a $20M hair cut on the valuation of your company. I’ve seen first hand a small company being courted by a bigger company; they send over a form asking about quality system, DC, RM, and if it’s not in place it’s going to cost you a lot of money.”
"As a design firm, our ISO 13485 certification is a competitive advantage. Greenlight Guru made getting it easy."
"I was actually a little nervous going into the audit, because it seemed too effortless."
By Jon Speer
Medical Product Outsourcing, October 7th 2018
By David DeRam
MedTech Intelligence, October 8th, 2018
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By Jon Speer
Medical Design & Outsourcing, September 24th, 2018
