Medical Device Complaints, MDR’s and Recalls 2012

Topics

• Complaint Documentation
• FDA’s Complaint Definition 820.3 (b)
• Part 803 – Medical Device Reporting
• Canadian & European Vigilance
• Warning letters and other FDA Remedies
• Part 806 – Reports of Corrections & Removals

Who should Attend

Manufacturing & Design Engineers, Quality Professionals, Regulatory Professionals and Marketing Product Managers.