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Detecting Trends in Medical Device Complaints
When device users complain, those complaints must be passed on – to the FDA, the EU and other regulators. Formats must be followed to the letter. And they vary from regulator to regulator. It’s a lot to keep track of.
The FDA’s QSR. International standards ISO 13485:2003 and ISO 13485:2016 ... The EU Vigilance system and the draft EU Medical Device Directive (MDR) ... Couldn’t you use help with your complaint reporting systems?
Join us for a training session that provides the tools to set up and maintain a smooth-running complaint reporting system.
You’ll learn the trend analysis method the EU Vigilance system recommends ... master classification systems including definition of a complaint, an ISO standard for coding adverse events, FDA coding for MDRS and coding derived from risk management files ... and, as a special bonus, receive a technical description of analysis methods that includes guidance on their use.
Here are just a few of the specific areas you’ll cover in 90 fast-paced minutes:
Your guide through the complaint-reporting maze is Dan O’Leary, a favorite presenter at dozens of FDAnews-sponsored workshops.
Conscientious, accurate complaint reporting not only pleases regulators ... it’s good business too, sharpening focus and deepening understanding of patient safety. Invest 90 minutes now and reap dividends for years to come.
Dan O’Leary, President, Ombu Enterprises, LLC
Dan O’Leary, a favorite presenter at dozens of FDAnews-sponsored workshops. Mr. O’Leary boasts 30+ years’ experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. His consultancy, Ombu Enterprises LLC, focuses on operational excellence and regulatory compliance particularly for small manufacturing companies. He 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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