“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 nervious going into the audit, because it seemed too effortless."
"We got FDA clearance of a class II medical device, in 93 days, with zero experience."
"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."