Greenlight Guru's State of Medical Device Product Development and Quality Management 2020 Report is here.
"We wanted a QMS solution that was robust enough to grow with us, but simple enough to get us started."
“Greenlight Guru has been instrumental for us while we efficiently navigate the quality management system process and with developing our FDA submission.”
"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.”
“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."
"Greenlight Guru has already paid for itself in the added value brought to us by successfully flying through our quality audit."
The results? "A tenfold increase in efficiency with Greenlight Guru."
"I believe the quality system I've institued actually gives me a competitive advantage against a lot of the large companies I used to work for."
"Less than 15 minutes later, the auditor had observed enough evidence to grant the scope expansion."
"The proof is in the pudding. We passed our California audit with flying colors. She was in and out in 2 hours and sent us our certificate in the mail, no questions asked."
