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Conference Directory
The 510(k) Process and Risk Management
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Venue Name: Online Webinar
Country: United States of America
City: Palo Alto
Number of Attendees: Unknown
Webinar or Virtual Event: Yes
Keywords: Regulatory Affairs,Risk Managers,Risk Management team members,Quality Engineering,Market Research,Clinical,MDR Reporters
Start Date of Conference:: 12-16-2009
End Date of Conference: 12-16-2009
Description of Conference: This 510(k) and risk management webinar /training will discuss FDA expectations for information supplied in the 510(k) application and how to best demonstration the product is safe.
Areas Covered in the seminar:
* What concerns were revealed in the internal report on the 510(k) process?
* What information can be gained from congressional statements?
* What is a "predicate" product in the 510(k) process?
* How can a manufacturer determine if the proposed product is as safe as the predicate device?
* How can a manufacturer best provide documentation in the 510(k) application demonstrating product safety?
* What changes to the 510(k) process have already been implemented?
* When can further changes to the 510(k) process be expected?
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