Tollfree - +1-888-222-5917

Complaints and Medical Device Reporting

Faculty :

Industry :

Duration :

Course Description:

Complaint Handling and Medical Device Reporting are considered critical processes by the FDA in maintaining the public safety. Because they are so critical they are frequently inspected areas by the FDA. More importantly, complaints can be also be an early warning of issues with your products and customer problems. It is vital to have efficient and effective processes for managing, analyzing, trending, and reporting product problems. This webinar will cover the basics of complaint management and medical device reporting. Complaint management and MDRs are critical quality systems to your 3 key stakeholders - the customer, the regulators, and your business.

Why should you Attend?

Complaint Handling and Medical Device Reporting are essential processes to ensure the safety and efficacy of your medical devices. As such, they are also frequently inspected by the FDA. It is critical that you understand and create efficient and effective processes.

Areas Covered:

  • The purpose of the New Rule
  • Overview and Definitions
  • FDA Expectations, Regulations
  • Lessons Learned and Enforcement Case Studies
  • Processes and Procedures
  • Reportability Criteria
  • Investigating a complaint or MDR
  • Linkages between Complaint Handling, MDRs, and CAPA
  • Common Mistakes and how to avoid them
  • Best Practices
  • Preparing for an FDA or NB Inspection
The Learning Objectives of this Session are:
  • Understand regulations and expectations
  • Review enforcement case studies for lessons learned
  • Determine needed processes and procedures
  • Identify best practices
  • Understand the linkage between complaints, investigations, MDR reports, and CAPA
  • Preparing a plan for inspection readiness

Who will benefit?

This webcast will be of a valuable assistance to the below audience.

  • Complaint Specialists and Managers
  • Complaint Handling Unit
  • Individuals participating in Failure Investigations
  • Individuals analyzing returned products / Complaint Analysis
  • Regulatory Affairs
  • Quality Engineers
  • Clinical Affairs
  • Compliance Specialists
  • Auditors
  • Senior Management
  • Field Sales

Registration Options

Avail 12 months unlimited access for a single user.

Material shipped within 15 days post webinar completion & get life time access for unlimited participants.

Speaker Details

Susanne Manz

Susanne Manz

Medical Device Consultant

Susanne Manz, MBA, MBB, RAC, CQA has a BS in Biomedical Engineering and an MBA from the University of NM.  She earned her Black Belt and Master Black Belt certifications while at Johnson and Johnson.  Susanne also holds Regulatory Affairs Certification (RAC) from RAPS and Certified Quality Auditor (CQA) certification from the American Society for Quality.  Susanne has now established a consulting business with a mission to provide services to help

Refund Policy

Participants/Registrants for our live events, may cancel up to 72 hours prior to the start of the live session and ComplyArena will issue a letter of credit to be used towards any of ComplyArena's future events. The letter of credit will be valid for 12 months.

ComplyArena will process refund in cases where the event has been cancelled and is not rescheduled within 90 days from the original scheduled date of the webinar. In case if a live webinar is cancelled, participants/registrants may choose between recorded version of the course or a refund. Refunds will not be processed to participants who do not show up for the webinar. A webinar may be cancelled due to unavoidable circumstances, participants will be notified 24 hours before the scheduled start of the event. Contact us via email: or call +1-888-222-5917 (Toll Free).