Medical Device Complaint Handling and MDR Reporting
Medical device manufacturers that market in the US need to collect and evaluate complaints. In addition, they must assess each complaint to determine if it requires a Medical Device Report (MDR). Both of these mandates require written procedures that are effectively implemented. This includes an appropriate organizational structure, trained people, and adequate records. FDA Investigators will check all of these criteria during a routine inspection.
Typically, there are three sources of information to assure you have a successful program:
- The regulations which inform you of the requirements
- FDA’s inspection documents which tell you how the Investigator checks your system
- Warning Letters to identify serious problems/trends resulting from inspections
Join our interactive online training course where you will learn how to apply these methods to your complaint handing and MDR systems, and learn the following:
- Understand how to develop and implement bullet-proof MDR Handling/Reporting programs
- How to train staff to adequately handle and document complaints
- Tips and tricks to save time and money
This course will help your organization ensure an integrated, efficient, and complaint system.
This course will benefit all personnel who are involved in the complaint handling and MDR processes.
Personnel that will find this course of particular benefit include:
- Complaint specialists
- MDR reporters
- Quality engineers
- Regulatory personnel
- Quality data analysts
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 Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and certified by APICS in Resource Management.