Managing Your Medical Device Reporting (MDR)Program for Compliance Success 2012

Key Topics

• Reporting device-related deaths and serious injuries and when these are not treated as a product complaint
• How will I know if I require more information about my medical device report?
• Are there exemptions, variances, or alternative forms of adverse event reporting requirements?
• The manufacturer`s reporting requirements and expectations
• Develop, maintain, and implement written MDR procedures and achieve compliance
• Learn what constitutes a MDR and how to facilitate this for compliance success
• Learn why FDA is amending its MDR regulations to remove a requirement for baseline reports that the agency deems no longer necessary

Who should Attend

• Regulatory Affairs and Compliance
• QA/QC
• Consultants
• Engineering/Technical Services/Operations