Medical Device 2012 - Equipment Calibration in FDA QSR ? Regulations and Warning Letters

This webinar explains concepts required for a calibration program that satisfies FDA’s Quality System Regulation (QSR), ISO 13485, and ISO 9001. It defines the concepts of accuracy and precision that define the measuring equipment’s requirements. It also explains the meaning of traceability.

Managing your calibration program is a key element in delivering good products and services. You must satisfy the QMS requirements but first you need to understand them. You need to know when a piece of equipment needs to be in the calibration recall program and when you can identify it as “no calibration required”.