Relying on a general purpose QMS for your medical device quality system leaves you exposed to compliance complexities and regulatory roulette.
Our software connects disparate processes, sources, people, and data for the first time ever. Increased visibility smooths your path to compliance and puts True Quality within reach.
"We adopted Greenlight Guru 18 months ago to build our QMS. We recently passed our ISO 13485 Stage 2 audit, due in part to the ability to demonstrate a comprehensive matrix of risk and design controls. Demonstrating our QMS using GG was fundamental in this achievement. I'll also say that the team at GG has been a phenomenal resource and support for us. I never feel like I'm weeding through the quagmire of compliance alone, they are part of our team."
Greenlight Guru has partnered with FDA to give you the inside track on what you need to know about the Case for Quality, the changing regulatory paradigm, and what all this means for all stakeholders involved with the medical device industry.
"I was actually a little nervious going into the audit, because it seemed too effortless."
How to start using FDA design controls to your benefit today & implement a process to actual improve your medical device product development efforts.