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.
Creation and Maintenance of Lean Quality Management Systems for Class I, 510(k) exempt Medical Device
Tackling FDA Quality System (QS) regulations can be confusing, especially for Class I 510(k) exempt medical devices. We know the challenges firsthand and have designed this course to make the process clearer and more engaging.
GLP Training for Early-Stage Companies: Laying the Foundation for Scientific Integrity
Imagine doing groundbreaking work in the lab but not getting the credit because your processes couldn’t scale. Don’t let that happen. Your science deserves better.
Navigating the intricacies of Good Laboratory Practice (GLP) can be overwhelming especially as technology evolves rapidly in today’s digital landscape.
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.