Preparing a US FDA Medical Device 510(k) Submission and Deciding When to Submit a 510(k) for a Change to an Existing Device 2017

Preparing a US FDA Medical Device 510(k) Submission and Deciding When to Submit a 510(k) for a Change to an Existing Device 2017 is dedicated to a broader perspective of how and what to do to get a quick and non-debatable or questionable approval for your 510K product by generating a technical comprehension and technical writing capabilities to eliminate corporate interpretations and translations of technical terms relative to the specifics of your specific process needed for a 510K submission.

Who should Attend

• Clinical Affairs Managers, Directors and VPs
• Regulatory Affairs Managers, Directors and VPs
• Compliance Managers and Directors
• Quality Managers, Directors and VPs
• Site Managers, Directors, and Consultants
• Complaint Handling and Risk Management Managers and Directors
• Quality Assurance
• Legal Counsel
• Executive Management, such as CEO, Owner, President, Vice President
• Product Development
• Manufacturers of medical devices
• Regulatory specialists who compose 510(k) applications for software
• Medical writers
• Project managers and documentation specialists