Live Webinar on
The 510(k) Submission: Requirements, Contents, and Options
Date & Time:
Tuesday, March 20, 2012 10:00 AM PST | 01:00 PM EST
Register Now
Duration: 60 Minutes Instructor: Jeff Kasoff
Location: Online Price : $245.00 (for one participant)
Instructor Profile:
Overview:
Jeff Kasoff
This presentation will provide an understanding of how to get a Director of Regulatory
device requiring a 510(k) submission to market quickly. Knowing Affairs, Life-Tech, Inc
when and how to properly submit a 510(k) for a device or change to
a device is critical to a company's regulatory and financial health. Jeff Kasoff, RAC, is the Director of
Quality at Byrne Medical, a leading
Your goal is to get the 510(k) through the review process as quickly manufacturer of endoscopy
as possible. This presentation will also distinguish between the products. In this position, Jeff is
responsible for supplier
standard, special and abbreviated 510(k)s, and explain when each is
management, during which he
appropriate. This course will describe the submission process and
reviews and approves supplier
the contents required by the FDA for a successful submission. It will qualification, selection, assessment,
also provide an understanding of the common pitfalls, delays, and and CAPA. Prior to this, Jeff spent 13
possible preventive measures. Also described will be the type of years at Life-Tech as the Director of
activities a company can pursue while waiting for submission Regulatory Affairs, where he was
clearance. responsible for regulatory
compliance of all aspects of the
quality system. Jeff received his
Areas Covered in the Session: regulatory affairs certification in
1996. ...more
l When to submit a 510(k) for a new or modified product
l Types of 510(k) submissions and when to use each
l What is the submission process Suggest a Topic More Webinars
l What is contained in a 510(k) submission package
Your Necessity is our Priority
l How to know whether clinical data is required
l How is the submission package assembled
l User fees and 510(k) submissions
l How to interact with the FDA and the reviewer
Click here to register for this webinar
Who Will Benefit:
This webinar will provide valuable assistance to all medical device
companies that prepare 510(k) submissions. The employees who will
benefit include:
l Executive Management
l Regulatory Management
l Professionals involved with premarket notification to the FDA
l R&D personnel involved in approving the design of medical
devices
l Sales personnel involved in approving the marketing of medical
devices
It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely
benefit from this program.
For more information, please contact the event coordinator. We look forward to seeing you at the webinar.
Best regards,
Event-coordinator
GlobalCompliancePanel
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