All available Prodct training courses
Preparing for Your First ISO 13485 Audit or FDA Inspection with Confidence and Humility
For small to mid-sized companies facing their first ISO 13485 audit or FDA investigation, the process can feel overwhelming. With so much at stake, it’s natural to worry about getting everything right.
Requirements Management - Best Practices for Medical Device Companies
Skip the fine print at your peril—because in the world of medical devices, the devil’s not in the details, it is the details.
Step into the world of “Requirements Management,” where we unveil the crucial details that turn user needs into actionable design inputs, ensuring your product not only meets user expectations but is also fully testable.
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.