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.
Our team will become an extension of your quality management team with regular consulting sessions, time-saving document packs and procedures, QMS setup and implementation support, staff training, regulatory submission strategy and much more.
If you need additional help outside the scope of our services, we have a growing list of preferred partners from around the world who know our eQMS, quality management and regulatory compliance just as well as we do.
“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,
Vitameter
We’ll implement an eQMS that will help ensure compliance with the relevant regulations your medical device is subject to, while also helping you bring your product to market in less time and with less risk.
We stay on top of the constant changes made to medical device regulations so that you don’t have to. No matter which markets you operate in, you can trust that our product, team and resources are up-to-date.
Your medical device products and company will be subject to audits in order to prove compliance to regulations. We can help set up the procedures and even help train your staff to help ensure you can provide proof of compliance when asked so that audits are as quick and-as painless as possible, while minimizing impact and consequences.
We can train your staff in regulatory and quality requirements specific to the type of medical device you produce and the markets you operate in. Use this training to manage quality and risk throughout the entire product lifecycle.
Whether it's through our phone support or in-app customer support, a real, friendly person is always a click away to help you with what you need. You can also get access to a pack of procedures and documents that can be used to meet 21 CFR Part 11 and Annex 11 requirements within the greenlight.guru eQMS.
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
