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Medical Devices 2011 - The 510(k) Process and Risk Management
Date2011-04-15
Deadline2011-04-15
VenuePalo Alto, USA - United States 
KeywordsMedical Devices,conference,event,Webinar
Topics/Call fo Papers
Why Should You Attend:
The majority of medical devices being placed on the US market are cleared through the Premarket Notification or 510(k) process. Recently FDA has indicated it is tightening this process after some controversy surrounding devices cleared for market. This controversy resulted in replacement of the Director of the Center of Devices and Radiological Devices. An internal report identified some issues and called for an external review of the process, which the FDA commissioned. Manufacturers need to prepare for the impact to product clearance for the US market.
NOTE: Use This Promocode ( 117660 ) To Get 10% Discount.
The majority of medical devices being placed on the US market are cleared through the Premarket Notification or 510(k) process. Recently FDA has indicated it is tightening this process after some controversy surrounding devices cleared for market. This controversy resulted in replacement of the Director of the Center of Devices and Radiological Devices. An internal report identified some issues and called for an external review of the process, which the FDA commissioned. Manufacturers need to prepare for the impact to product clearance for the US market.
NOTE: Use This Promocode ( 117660 ) To Get 10% Discount.
Other CFPs
- Basics of testing associated with sterilization validation and routine processing
- Verification vs. Validation in Regulated Industries
- Medical Device Complaints, MDR’s and Recalls
- The Medical Device Professional's Guide to Successfully Preparing 510(k) Submissions & Regulatory Compliance
- Compliance with FDA’s Current Manufacturing Requirements
Last modified: 2011-03-11 18:51:11