510(k) Update - How to Format Succinct and Comprehensive 510(k)s 2019

510(k) Update - How to Format Succinct and Comprehensive 510(k)s 2019 provides knowledge on what to consider and how to prepare for premarket notification 510(k)s and submit to the FDA.

Topics

• Overview of 510(k) Program and Changes
• Laws, Regulations and Definition
• Review of Relevant and Applicable Guidance Documents and Standards
• 510(k) Regulatory Requirements
• Quality System Regulations
• Systematic Methods to Increase 510(k) Submission Quality
• 510(k) Contents
• How to Format a Succinct and Comprehensive 510(k) Submission
• What to Ensure While Preparing for a 510(k) Application
• Common Pitfalls and How to Prevent Them: Dos and Don’ts
• Resolving Different Opinions and Interpretations: Dos and Don’ts
• Responding to FDA’s Request of Additional Information

Who should Attend

Attendees from:

• Medical Devices Quality Departments
• Pharmaceutical Quality Departments
• Pharmaceutical Compliance Departments
• Regulatory Affairs Departments
• CEOs
• Medical Devices Compliance Departments
• Attorneys
• VPs
• R&D Departments
• Clinical Affairs Departments
• Contractors/Subcontractors
• Consultants
• Everyone responsible or Interested in the 510(k) Matters