Medical Device Complaint Management 2015

precon

8:00 a.m. – 9:00 a.m.

Registration and Continental Breakfast

9:00 a.m. – 10:15 a.m.

Part A – The Intersection of Complaints and the Regulatory Structure

  • Understanding the Quality Management System (QMS) in the US, EU, and Canada
  • Distinguishing records and reports to regulatory agencies (content, trigger, and timing)
  • How and why the FDA conducts inspections and the guiding documents they use
    • Quality System Inspection Technique
    • Compliance Program 7382.845 Inspection of Medical Device Manufacturers
  • Using sampling plans as part of the Medical Device Directive (MDD) audit

Exercise – FDA Inspection Levels
Exercise – QSIT sampling plans for records

10:15 a.m. – 10:30 a.m.

Break

10:30 a.m. – 12:00 p.m.

Part B – How Newly Enacted Unique Device Identification Will Impact Complaints

  • Overview of the US regulations regarding UDI
  • What are Device Identifiers and Production Identifiers — and how do they differ
  • Understanding the GUDID and the information you need to supply

Exercise – Creating a new Device Identifier

Part C – Servicing: The Front Line for Complaints?

  • Definition of servicing — is your definition and regulators’ the same?
  • How servicing relates to other QMS elements?
  • Producing service records and linking them to complaints
  • Tips, tools, and techniques for analyzing service records; what should you be looking for?

Exercise – Analyze a small set of service records using quality tools

12:00 p.m. – 1:00 p.m.

Lunch Break

1:00 p.m. – 2:30 p.m.

Part D – Complaints

  • Definition of a complaint —distinguishing regulatory complaints from customer service complaints
  • Comparing and contrasting QSR vs. ISO 13485 definitions
  • Successfully developing and managing complaint classification systems
  • Fully understanding complaint system interrelationships, it’s harder than it appears
    • Complaints and corrective action
    • Complaints and MDRs
    • Complaints and EU Vigilance
    • Complaints and risk management (ISO 14971:2007)
  • Complaint system flowchart
  • Determining the required content for complaint records

Exercise – Analyze customer reports to determine if they are a complaint and potentially reportable

2:30 p.m. – 2:45 p.m.

Break

2:45 p.m. – 4:30 p.m.

Part E – Medical Device Reports (US)

  • Understanding the criteria for reporting
  • Establishing the MDR event files that serve their purpose and stand up to FDA scrutiny
  • Identifying Designated Individuals
  • MDR system interrelationships
  • Examining the nexus between MDRs and complaints
  • Getting to know the types of MDRs (30 day and 5 day)
  • Reporting MDRs — paper or electronic
  • Records required for the MDR system — what you must have

Exercise – Initiate a Medical Device Report

Part F – Medical Device Reports in the EU and Canada

  • Understanding the criteria for reporting
  • The regulatory structure in the EU (MDD and MedDev)
  • The regulatory structure in Canada
  • Role of the Notified Body in the Vigilance System
  • Role of the MDD Authorized Representative in the Vigilance System

Exercise – Analyze an adverse event to determine when to report

4:30 p.m.

Session Wrap-up, End of Day One

 

register

Day 1 | Day 2

Back to Top