Live webinar on The 510(k) Submission: Requirements, Contents, and Options

FOR IMMEDIATE RELEASE
Houston, Texas, United States of America (Free-Press-Release.com) January 19, 2012 --

This presentation will provide an understanding of how to get a device requiring a 510(k) submission to market quickly. Knowing 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. Your goal is to get the 510(k) through the review process as quickly as possible. This presentation will also distinguish between the standard, special and abbreviated 510(k)s, and explain when each is appropriate. This course will describe the submission process and the contents required by the FDA for a successful submission. It will also provide an understanding of the common pitfalls, delays, and possible preventive measures. Also described will be the type of activities a company can pursue while waiting for submission clearance.



Why should you Attend



It's routine practice for Sales to identify a market opportunity, and require market penetration ASAP. If your company lacks personnel who are experienced in the requirements and nuances of 510(k) preparation, this market opportunity could wither on the vine. Repeated occurrences of such lack of 510(k) knowledge may very well have a negative impact of corporate solvency.



Areas Covered in the Session



- When to submit a 510(k) for a new or modified product

- Types of 510(k) submissions and when to use each


- What is the submission process


- What is contained in a 510(k) submission package


- How to know whether clinical data is required


- How is the submission package assembled


- User fees and 510(k) submissions


- How to interact with the FDA and the reviewer


- What do to if you make a change to your device



Who will benefit: (Titles)

This webinar will provide valuable assistance to all medical device companies that prepare 510(k) submissions. The employees who will benefit include:


- Executive Management


- Regulatory management


- Professionals involved with premarket notification to FDA


- R&D personnel involved in approving the design of medical devices


- Sales personnel involved in approving the marketing of medical devices



About Speaker

Jeff Kasoff, RAC, is the Director of Quality at Byrne Medical, a leading manufacturer of endoscopy products. In this position, Jeff is responsible for supplier management, during which he oversees supplier management, CAPA, and document control. Prior to this, Jeff spent 13 years at Life-Tech as the Director of Regulatory Affairs, where he was responsible for regulatory compliance of all aspects of the quality system. Jeff received his regulatory affairs certification in 1996.

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