Medical Device Complaint Management

precon

8:00 a.m. – 8:30 a.m.

Continental Breakfast

8:30 a.m. – 10:15 a.m.

Part F – Adverse Event Reporting

  • The concept of an adverse event
  • Implementing the US system
  • Implementing the Canadian system
  • Implementing the EU system under the MDD
  • Implementing the EU system under the MDR

Exercise F1 — Adverse Event Reportability


10:15 a.m. – 10:30 a.m.

Break

10:30 a.m. – 12:00 p.m.

Part G – Corrective Action and Preventive Action (CA&PA)

  • The difference between corrective action (CA) and preventive action (PA)
  • Understanding CA&PA interrelationships in the QMS
  • Implementing CA&PA in QSR
  • Implementing CA&PA in ISO 13485:2016
  • Applying CA to complaints

Exercise G1 — Complaints Requiring Corrective Action

12:00 p.m. – 1:00 p.m.

Lunch Break

1:00 p.m. – 2:30 p.m.

Part H – Design Changes

  • Understand the role of design changes in the QMS
  • Design change additional elements
    • Production change
    • UDI changes
    • Updated submissions
    • Risk management
    • Field actions
  • Developing the design change process in QSR
  • Developing the design change process in ISO 13485:2016
  • Design changes driven from CA from a complaint

Exercise H1 — Complaints Requiring Design Changes

Part I – Field Action

  • Understand the role of field action in the QMS
  • Implementing the US system
  • Implementing the Canadian system
  • Implementing the EU system under the MDD
  • Implementing the EU system under the MDR

Exercise I1 — Field Action Determination

 

2:30 p.m. – 2:45 p.m.

Break

2:45 p.m. – 4:30 p.m.

Part J – Regulatory Submission

  • Understanding the role of regulatory submissions in the QMS
  • Implementing the US system for 510(k) devices
  • Implementing the Canadian system
  • Implementing the EU system under the MDD
  • Implementing the EU system under the MDR

Exercise J1 —Determining the Need for a Regulatory Submission

4:30 p.m.

Adjourn Workshop

 

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