Medical Device Complaint Handling 2016

Topics

• A complaint may represent a serious event reportable to regulatory authorizes. The workshop helps you understand the FDA reporting requirements for Medical Device Reports (MDRs) and the corresponding reports for the EU and Health Canada. Each of these systems has different definitions, thresholds, and time frames
• Complaints can lead to investigations that lead to corrective action. The workshop explains how to investigate complaints and perform corrective action using the elements of your QMS. It helps establish the interfaces between these systems, designate individuals, assign responsibility, and assure the required skill set
• The corrective action may lead to a field action, potentially requiring a report to FDA. However, there are complex exceptions to the reporting requirements that may create a record, but not a report. The workshop will help you understand the requirements, establish regulatory timelines, and implement a compliant approach. In addition, handling field actions in the EU and Canada involves a different regulatory structure
• The corrective action may lead to design changes. Does the design control system handle these changes? Do you know how to evaluate the change for an updated 510(k)? How does the change affect the UDI? Documenting the change in a Technical File or Design Dossier is very important in the EU
• Complaints are an essential element for the post-production evaluation required by an ISO 14971:2007 (EN ISO 14971:2012) quality management system. You will learn how to update the risk management file and take action to reduce risk

Who should Attend

Attendees from:

• QA/QC/Compliance/Regulatory Affairs
• All levels of Management for all departments and those who desire a better understanding
• Engineering/Technical Services
• Marketing & Sales & Customer Service
• Operations and Manufacturing
• Consultants