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Secrets of Medical Device Complaint Management: From Customer Service to Corrections and Removals

April 2013

When one of your medical devices triggered a consumer complaint, you responded immediately. You dotted all the i’s and crossed all the t’s. You thought you’d taken every prescribed step.

And still you got a warning letter. What went wrong?

What you may not realize is that FDA scrutiny can probe every aspect of your operation — customer service, field servicing, sales, device reporting, CAPA, design change, corrections and removals, and more.

You need a systemwide solution — one that turns your entire operation into a well-oiled complaint-handling machine. If you aren’t sure how to pull it off…

Here’s just a sampling of what’s covered in this three-hour video tutorial:

  • Differences in complaint management definitions and requirements between U.S. regulations and international standards
  • Rules and timelines for reporting serious adverse events
  • Kinds of records to keep to support complaint decisions and actions
  • Definitions and explanations of key terms such as serious injury, permanent damage, malfunction, corrections vs. removals, and more
  • What the FDA means by the all-important, but frustratingly vague phrase, “receive or otherwise become aware of information”
  • How to calculate the deadline for filing a Medical Device Report with the FDA and what that report should include
  • Who can make the decision not to report a complaint and how to support that decision
  • How the FDA’s proposed rule for Unique Device Identifiers will impact the complaint process
  • And much more

It’s a lot of ground to cover. Many devicemakers — especially smaller ones — have no idea where to start.

Fortunately, your instructor does.

Dan O’Leary, principal of Ombu Enterprises, shares lessons learned in 30 years of work in the quality and operational excellence fields.

This three-hour video presentation brings Mr. O’Leary right into your office to explain the regulatory requirements, both in the U.S. and abroad, and help you integrate all your operations into a cohesive complaint management system.

Here’s what you’ll get:

  1. A complete course in device complaint management, from initial complaint through company integration to FDA reporting — three hours of video instruction from a top-rated expert consultant, plus
  2. 9 checklists to keep you compliant at every stage, plus
  3. Excel spreadsheet that asks you questions, calculates the answers and tells you what to do next, plus
  4. FDA and international guidances and directives that impact every devicemaker’s complaint management activities, plus
  5. Printable copy of all 200+ slides in the video presentation, plus
  6. Copy of FDAnews’ in-depth report, Secrets of Medical Device Complaint Management: A Guide for Compliance.

Why risk a warning letter … or worse … when it’s this easy to take matters in hand? Start whipping your operation into shape.

Dan O'Leary, President, Ombu Enterprises

Dan O’Leary has more than 30 years of experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. Dan is now President of Ombu Enterprises, LLC a consultancy focused on operational excellence and regulatory compliance serving small manufacturing companies. He has a Masters Degree in Mathematics; is an ASQ Certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.

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