Relying on a general purpose QMS for your medical device quality system leaves you exposed to compliance complexities and regulatory roulette.
Our software connects disparate processes, sources, people, and data for the first time ever. Increased visibility smooths your path to compliance and puts True Quality within reach.
“Greenlight Guru’s postmarket suite allows us to easily link and connect nonconformances, complaints, audit ﬁndings, CAPAs and documents. Now we can put our focus squarely on the quality of our devices.”
Learn how to implement and maintain a risk-based CAPA process while avoiding the most common pitfalls at your medical device company.
Here are 15 items medical device startups need to address early on as a best practice to ensuring FDA / ISO regulatory compliance.
Insights into the new risk-based changes and specifics on how to comply with the standard.