All available Prodct training courses
Risk Management ISO 14971 Training
Creating a risk-minded culture in medtech is hard. Risk Management can be boring and confusing. We get it... we’ve struggled too.
Built from our own trials and triumphs, this course offers well-traversed pathways to implementing risk management in regulated organizations in a fun and interactive way.
Risk-Ready: Mastering Essential Tools for Medical Device Success from Concept to Market
Start strong, finish stronger: Master the tools that safeguard your medical device from concept to market.
For early-stage medical device companies, effective risk management is critical from the very beginning of product development through to market launch and beyond.
Introduction to QMSR
Ready or not, QMSR is coming! - The FDA's new QMSR won't wait for you to catch up. Scared? Feeling Lost? That’s understandable. We are here to help ensure your Quality Management System is ready.
In February 2024, the FDA introduced new Quality Management System Regulations (QMSR) to incorporate ISO 13485:2016 by reference, creating significant changes in the compliance landscape by February 2026. If your QMS is primarily structured around the previous FDA regulations, or if you're a startup beginning to build your quality system, planning a smooth transition is crucial.