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Case Studies

Innovative medical device companies like yours who have found success with greenlight guru.

More than 150,000 rely on us for the latest in quality

How Puzzle Medical is Putting Together the Pieces for Success with Greenlight Guru

"Greenlight Guru was instrumental in implementing our quality system. With them, we can bring safer, higher-quality medical devices to success while maintaining a quality culture throughout our entire device lifecycle."

How a Partnership with Greenlight Guru is Making This Dental Device Manufacturer Smile

“Partnering with Greenlight Guru provides you with a team that’s on your side, who are all medical device industry pros and understand what companies like ours go through.”

How The Partner Ecosystem Has Been Key To Market Success For Spark Biomedical

“Having partners with common values is just as important as the product or services themselves.”

6 Tips for a Seamless Document Migration to Greenlight Guru

"Greenlight Guru provides an Electronic Quality Management System (eQMS) for medical device companies to ensure quality standards are met without requiring that the end user be a ‘quality guru’."

How IVD Manufacturer Streamlined Production and Improved Quality Processes with an Industry-Specific QMS

"If I were to quantify it, it's days of time saved. The cost of Greenlight Guru is repaid in efficiency."

How Delta Development Fast-tracked R&D Down to a Single Year by Implementing a MDQMS

"Greenlight Guru was the only way we could get our small team to move really quickly with a QMS."

How Flexlogical Is Making Quality A Competitive Advantage By Adopting Data-driven Approach With MDQMS

"Showing traceability and documenting takes seconds in Greenlight Guru, compared to hours in a paper-based system."

C2DX, INC. Impresses Auditors and Achieves MDSAP Certification After Implementing Medical Device QMS (MDQMS)

"We wanted a QMS solution that was robust enough to grow with us, but simple enough to get us started."

Photonicare Adopts Medical Device QMS Software to Accelerate Time to Market

“Greenlight Guru has been instrumental for us while we efficiently navigate the quality management system process and with developing our FDA submission.”

Centese Trades in Paper-Based QMS for Medical Device Success Platform & Achieves 510(K) Clearance

"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."

How Innovere Has Accelerated Their Path To Market By Implementing Greenlight Guru’s Medical Device Specific eQMS

"With Greenlight Guru, you've got software, but also what amounts to a personal consultant. Those connections are powerful."

Lucerno Dynamics Has Simplified the ISO 13485:2016 Certification Process with Greenlight Guru

"I highly recommend Greenlight Guru. They have taken a complex industry and made it into a product that’s simple to use.”

How a Partnership with Greenlight Guru Helped Rook Quality Systems Grow 5X In Two Years

“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.”

How Priority Designs Used Greenlight Guru to Gain ISO 13485:2016 Certification

"As a design firm, our ISO 13485 certification is a competitive advantage. Greenlight Guru made getting it easy."

How SOLIUS Went from Scratch to an eQMS and ISO 13485:2016 Certification

"I was actually a little nervous going into the audit, because it seemed too effortless."

How a New Breed of Medical Device Companies Is Leveraging Technology to Get More Done with Less Resources

"Greenlight Guru has already paid for itself in the added value brought to us by successfully flying through our quality audit."

Recovery Force Accelerates Their Product Development Efforts Using Greenlight Guru

The results? "A tenfold increase in efficiency with Greenlight Guru."

The Greenlight Guru Advantage - More Than QMS Software

"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."

LITG Case Study: Easily Documenting Design Controls to Accelerate Product Development

"Less than 15 minutes later, the auditor had observed enough evidence to grant the scope expansion."

Sandstone Diagnostics Case Study: Moving from a Paper-based QMS to Greenlight Guru

"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."