Medical Devices 2012 - DMR & DHR - What Is Really Required

This 90-minute training will discuss the FDA's QSR requirements for a Device Master Record (DMR) and how you can use it to build your Device History Record (DHR). You will learn what to keep in each record and organize them to help you lower cost in the QMS and provide valuable information when you need to investigate a problem and take corrective action.
Why Should You Attend:
Have you ever been confused about what needs to be in your Device Master Record (DMR) and your Device History Record (DHR)? This webinar will help you understand the requirements and assemble a complaint DMR and use it to build your DHR.
Areas Covered in the Seminar:
- The FDA’s QSR.
- The source of the requirements
- The preamble
- The QSR Manual
- OMB information collection
- Key Definitions
- Design History File (DHF).
- Requirements
- Content
- Quality System Record (QSR)
- Device Master Record (DMR)
- Contents
- Linkage to Design Controls
- Lessons for Implementation
- Device History Record (DHR)
- Contents
- Linkage to the DMR
- Lessons for Implementation