Global Medical Device Reporting - A Comparison of Worldwide Regulations 2013

Key Topics

• Medical Device Vigilance
• Edical Device Reporting
• Serious injury
• Malfunction
• Who Reports
• Incident
• Timing requirements
• Decision Trees – when to report
• Regulatory agencies next steps
• Comparison of format of reports
• Similar products
• Capital equipment
• Social Media
• Maude Database
• Alternative Summary Report (ASR)
• EMDR
• Remedial Action Exemption (RAR)

Who should Attend

• Medical Device Regulatory affairs professionals
• Medical Device Quality professionals involved in post market surveillance activities
• Consultants in the global medical device regulatory space
• Medical Device Quality Managers / Quality Directors / Quality VPs
• Auditors
• Medical Device Quality Engineers / Quality Assurance Professionals