Uncovering and Managing Successful Post Market Compliance for Medical Devices 2018

Topics

• Firms MDR reporting and FDA`s handling of MDR reports
• How to comply with complicated Compliant Handling, MDR and Recall requirements
• Risk of regulatory enforcement actions
• Company preparation in the event of a Recall, recall strategy, notification letter and communicating with the FDA
• Relationship and interaction with other quality system elements as they relate to complaints and reportable events
• Creation and maintenance of effective procedures for handling complaints, reportable events and recalls
• Designing Standard Operating Systems for communicating process for firm`s success
• Case examples
• FDA`s New Guidance`s on Risk and how it interacts with Recalls

Who should Attend

Attendees from:

• QA/QC
• Regulatory Affairs
• Regulatory Professional
• Project Managers
• Complaint Handling Teams
• Risk Managers
• CAPA Teams