Medical Device 2012 - One and Half-day In-person Seminar: Obtaining and Marketing Your 510(k) with Today's FDA, a 510(k) Workshop

Knowing how to get your 510(k) application through FDA quickly can save millions of dollars in unnecessary investment burn.

Mark DuVal, a national authority on the 510(k) program is in Silver Spring, Maryland at FDA nearly twice a month negotiating 510(k)/IDE/PMA issues for his clients. He will teach you the basics and advanced knowledge of the 510(k) program. He will also provide insights in what FDA looks for in 510(k) submission and common mistakes companies make in drafting 510(k)s. This will include insights and commentary on CDRH’s new proposals for the 510(k) program. He will also discuss the plusses and minuses of pre-IDE meetings and how to approach them.

Who will Benefit:
- CEOs
- VPs, Directors and Heads of: Quality Assurance, Compliance, - Validation & Regulatory Affairs
- Regulatory affairs
- Attorneys
- Quality Assurance
- Risk Managers
- Risk Management team members
- Quality Engineering
- Market Research
- Clinical
- MDR Reporters
- Production
- Engineering & R&D
- Professionals involved with premarket notification to the FDA
- R&D personnel involved in approving the design of medical devices
- Sales personnel involved in approving the marketing of medical devices