Medical Devices 2011 - Medical Device Complaints, MDR’s and Recalls

Why Should You Attend:
All Medical Device firms need to be aware of the benefits of compliance, as well as the dangers of inadequate complaint handling.

Many medical device firms face regulatory issues as a result of inadequate complaint handling. FDA has explicit complaint handling requirements and poor complaint & reporting procedures often result in costly recalls and warning letters.

FDA warning letters and recalls are posted on FDA’s website and published in trade magazines, newspapers available to firm’s competitors, and has even driven the firm’s stocks down. This presentation will review the regulations and point out some of the pitfalls in complaint handling and reporting.

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