In-depth guide covering the requirements of 21 CFR Part 820, FDA's quality system regulation for medical devices, including tips on how to comply and avoid common pitfalls.
In-depth guide for medical device companies on how to control documents and improve procedures, with actionable solutions to common problems with document control activities and methods for implementing a document management system that enables product and business success.
Learn the most up to date recommendations and best practices from the ISO 14971:2019 standard and how you can start to use risk management as a tool - not a checkbox activity.
The best QMS software comparison guide for medical device companies that will help you choose a quality management system solution that strategically benefits your product and company.
A free, in-depth webinar exploring what is and is not a regulated medical device and how manufacturers can interpret and leverage FDA's definition of a device.
A free, in-depth webinar covering the challenges medical device companies face today when demonstrating closed-loop traceability, the growing emphasis from industry standards and regulations, and the strategies, tactics, and tools device professionals can use to achieve truly connected quality.
A free, in-depth webinar covering the best tools and tricks for manufacturers of in vitro diagnostic devices to meet IVDR requirements and obtain CE Marking.
A free, in-depth webinar covering proven methods to improve your CAPA processes and tactical approaches you can start taking today to ensure the medical devices you design, develop, manufacture and market are safe and effective.
Co-founder & CEO, Centese
President, CEO, Koios Medical,
CFO, Koios Medical,
Director of Regulatory Compliance and Quality, Koios Medical
Principal/Co-founder, Two Harbors Consulting
"Showing traceability and documenting takes seconds in Greenlight Guru, compared to hours in a paper-based system."
"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."
By Jon Speer
Medical Device and Diagnostic Industry (MD+DI), November 12th, 2020
By Jon Speer
Quality Digest, September 29th, 2020
By Jon Speer
Medical Product Outsourcing, September 24th, 2020