Device Master Record & Device History Record – requirements, contents and implementation - Webinar (Medical Device)

Venue: Online Event

Location: Palo Alto, California, United States

Event Date/Time: Feb 29, 2012 End Date/Time: Feb 29, 2012
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Description

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.

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Venue

Online Event
2600 E. Bayshore Road
Palo Alto
California
United States
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