Comprehensive guide to help medical device companies learn about training management, including compliance requirements and proven ways to promote total competence of the members of a medical device organization.
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.
A free, in-depth webinar explaining how to transform the change management process from reactive to predictive quality through AI/ML technologies that enable proactive decision-making and improvements to made throughout the change process.
Free interactive webinar demonstrating how to integrate change management and risk management and will share best practices using case studies from a variety of clinical specialties.
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.
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
"Greenlight Guru was the only way we could get our small team to move really quickly with a QMS."
"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.”
By Nick Tippmann
Medical Product Outsourcing, December 4th, 2020
By David DeRam
Inside INdiana Business, December 3rd, 2020
By Jon Speer
Medical Device and Diagnostic Industry (MD+DI), November 12th, 2020