Medical Device Complaint Management

precon

8:00 a.m. – 9:00 a.m.

Registration and Continental Breakfast

9:00 a.m. – 10:15 a.m.

Part A – The Regulatory Framework

  • QMS and RMS standards
  • Transition time lines for standards and certificates
  • Transition timelines for the EU-MDR and EU-IVDR
  • FDA warning letters — Learning from others

Part B – Overview of Connections

  • Definitions of Complaints
  • Linkage to Servicing
  • Linkage to Risk Management
  • Linkage to Corrective Action
  • Linkage to Adverse Event Reports
  • Linkage to Field Action
  • Linkage to Design Changes
  • Linkage to Regulatory Submissions

Exercise B1 — Preliminary Analysis of Complaint Implications

10:15 a.m. – 10:30 a.m.

Break

10:30 a.m. – 12:00 p.m.

Part C – Servicing: A Common Source of Complaints

  • Understanding Servicing – No clear definitions
  • Servicing as an element of the QMS
  • Service records and complaints
  • Warranty, servicing, and complaints
  • Service record analysis — complaint identification

Exercise C1 — Service Record Analysis to Detect Complaints

12:00 p.m. – 1:00 p.m.

Lunch Break

1:00 p.m. – 2:30 p.m.

Part D – Complaint Management

  • Definitions of a complaint
  • Identifying regulatory complaints
  • Complaint classification systems
  • Implementing a QSR complaint management system
  • Implementing an ISO 13485:2016 complaint management system

Exercise D1 — Complaint Classification

2:30 p.m. – 2:45 p.m.

Break

2:45 p.m. – 4:30 p.m.

Part E – Complaint Metrics and Reporting

  • Analysis of complaints in QSR
  • Analysis of complaints in ISO 13485:2016
  • Using complaint analysis to update the risk management file
  • Trend analysis and reporting in the EU-MDD
  • Trend analysis and reporting in the EU-MDR

Exercise E1 — Complaint Process Analysis

4:30 p.m.

Session Wrap-up, End of Day One

 

register

Day 1 | Day 2

Back to Top