Medical Device Complaint Management and Vigilance Training

What You Will Learn

At the conclusion of this workshop, you will be able to:

• Describe the role of risk management and CAPA in effective complaint handling, as well as key regulatory requirements for handling complaints, vigilance, and field actions.
• Identify best practices for structuring your complaint-handling process and department.
• Perform complaint intake, triage, investigation, and closure with confidence.
• Identify reporting requirements in the US, EU, China, and MDSAP countries.
• Understand PMS requirements, including those in the EU Medical Device Regulation (2017/745) and ISO 13485:2016.
• Apply a risk-based approach to needed corrections and removals.
• Prepare your team for audits of your complaint-handling system, including those by FDA, Notified Bodies, and MDSAP auditors.
• Explain the relationship to risk management using ISO 14971 and linkages with corrections, removals, and recalls.

Who Should Attend

Quality and regulatory managers in medical device companies or anyone who needs to understand and apply the regulatory requirements for complaint handling and event reporting. All attendees must have a basic familiarity with FDA 21 CFR Part 820 and ISO 13485.

Number of Days: 3
CEUs: 2.5

Related Courses

• Medical Device CAPA Training: Optimizing Your Programs
• ISO 14971 Medical Device Risk Management Training
• Medical Device Root Cause Analysis Training