Medical Devices 2011 - Device Master Record & Device History Record ? requirements, contents and implementation

Why Should You Attend:
The FDA’s QSR expects the manufacturer to maintain a series of documents that describe the design and production of the device. These are Design History File (DHF), Device Master Record (DMR), Device History Record (DHR), and Quality System Record (QSR). An FDA inspection will focus on the records you maintain. These records provide the objective evidence that demonstrates your QMS operates the way it should. While procedures are important, the supporting records demonstrate that you follow your own procedures.

This webinar explains these requirements from QSR and explains the role of each document type. The webinar uses the QSR preamble to explore FDA’s thinking, FDA guidance documents for recommendations, and Warning Letters to help participants learn from other firm’s experience. This webinar provides the information about contents of the records and lessons for implementation.