Obtaining and Marketing Your 510(k) with Today's FDA, a 510(k) Workshop 2012

Key Topics

• Insights in what FDA looks for in 510(k) submission and common mistakes companies make in drafting 510(k)s
• The basics and advanced knowledge of the 510(k) program
• Plusses and minuses of pre-IDE meetings and how to approach them
• Insights and commentary on CDRH’s new proposals for the 510(k) program

Who should Attend

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