Live webinar on The 510(k) Submission Process By Compliance2go 2011
01 Dec 2011
Webinar
Key Topics
Types of 510(k) submissions
When to submit a 510(k) for a new or modified product
What is contained in a 510(k) submission package
The submission process
How is the submission package assembled
How to know whether clinical data is required
How to interact with the FDA and the reviewer
User fees and 510(k) submissions
What do to if you make a change to your device
Who should Attend
Regulatory management
Executive Management
R&D personnel involved in approving the design of medical devices
Professionals involved with premarket notification to FDA
Sales personnel involved in approving the marketing of medical devices
Past Events
Live webinar on The 510(k) Submission Process By Compliance2go 2011 - 01 Dec 2011, Webinar (21340)
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Important
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