We’ll help you understand regulatory requirements, assist with any compliance related issues and help avoid expensive and time-consuming surprises.
We’ll help address your quality and compliance tasks, help you bring new products to market faster and help you expand into new markets.
We’ll streamline your product team’s processes and systems, ensuring they’re able to rapidly innovate and launch compliant medical devices in any market.
“The staff at greenlight.guru are extremely knowledgable and helpful. They onboard you, teach you how to use the software, and help you navigate the intricate, and complicated, world of quality management for medical devices.”
Niru Udayakumar, Co-Founder,
Our team will become an extension of your quality management team with regular consulting sessions, time-saving QMS document packs and procedures, QMS setup, and regulatory submission strategy.
For teams who have little to no quality and/or regulatory expertise on staff. You receive everything offered in the Boost Package plus additional regular consulting sessions, ISO 13485 & FDA 21 CFR Part 820 QMS training, Design Control training and Risk Management training.
“We've been using greenlight.guru for the better part of a year now and it really simplifies quality management. It's very easy to get all of our team on the same page and effortlessly trace various efforts through the system. The greenlight.guru team is one of the best I've ever worked with. They bend over backwards to help you reach your goals. They are fantastic partners.”
Ryan Shelton, CEO, PhotoniCare