Device Complaint Management: A Practical Guide to Evaluating, Investigating and Reporting
The FDA expects you to know and react immediately to reports that your device might have put someone in danger. Do you know the difference between a customer who’s unhappy with your device versus one who’s at risk from your device?
The complaint needs to be classified, the root cause investigated, corrective and preventive actions developed and details provided to the agency — promptly. There are a lot of decisions you need to make.
Device Complaint Management: A Practical Guide to Evaluating, Investigating and Reporting outlines all the factors you need to consider in handling complaints, how they interact and how to navigate through the regulations:
- Determine what systems are impacted by the complaint
- Meet the correct reporting deadlines — 30 days versus 5 days
- Understand the differences and similarities in U.S. and EU requirements
- Know the role of ISO 13485 and 14971 in complaint management
- Ascertain when a complaint qualifies as a Medical Device Report (MDR)
- Comprehend the links between complaint management, risk management, adverse event reporting and more
Customer complaints are inevitable but you can be prepared. This management report provides interactive exercises to train yourself and your staff for the many challenges of complaint management. Order your copy today.
About the Contributor
Dan O’Leary, President, Ombu Enterprises, LLC
Dan O’Leary is President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence focused on analytic skills and a systems approach to operations management. Dan has more than 30 years’ experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a master’s 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.
Who Will Benefit
- Compliance personnel
- Regulatory affairs professionals
- QA/QC personnel
- Manufacturing managers
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