15th Annual Medical Device Quality Congress


8:00 a.m. – 8:30 a.m.

Registration and Continental Breakfast

8:30 a.m. – 12:00 p.m.

Effective Complaint Management

A strong complaint management program can help medical device manufacturers make continuous improvements in regulatory compliance, patient safety and customer satisfaction. Unfortunately, many don’t manage the process well. Medical device manufacturers receive more Warning Letter citations for complaint management than for anything else save corrective and preventive action. And it’s not just domestic concerns. Regional compliant management requirements from the directives and regulations in the EU have to be dealt with as well.

This pre-conference workshop provides information to ensure your complaint management processes can survive an FDA Inspection without a 483, and provides the tools you need to write robust procedures, analyze complaint data, and perform rigorous internal audits that can satisfy domestic and international authorities. These are not simply principles listed on a power point slide, but real workshop exercises that can help illuminate the issues, and make sure you feel ready to improve your program when you return to the office.

And, although the QSR complaint management process is extensive, it still doesn’t meet all of the ISO 13485:2016 requirements. Complaint management also is an essential part of ISO 14971:2007. The workshop will explain how to implement a broad system to satisfy these quality management and risk management requirements too, including how to use inspection and audit tools such as QSIT and the MDSAP Audit Model.

Workshop leader:
Dan O’Leary, President, Ombu Enterprises LLC



Pre-conference | Day 1 | Day 2 | Post-conference

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