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:
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:
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:
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.