How does one take a medical device idea on a napkin to a 510k approval to market release as efficiently as possible? How does one manage risk to drive the safety and quality of products and processes, while striving to be first in a innovative market? How does one change their company’s focus from simply meeting regulations to building quality into their processes as a differentiator?
How does one understand and stay ahead of the FDA and EU changing quality regulations as leaders instead of followers? In this episode of DeviceAlliance’s Medtech Radio, we speak with Founder of Greenlight Guru, Jon Speer. Join us as he shares his deep insights in the differences that help medical devices get to market faster with less risk. Greenlight Guru is the only quality management software platform designed specifically for medical devices companies. The platform helps companies get safer products to market faster, simplifies FDA and ISO regulatory compliance and provides a single source of truth by connecting the management of all quality processes like CAPAs, risk, audits and more.