When one of your medical devices triggered a consumer complaint, you responded immediately. You dotted all the i’s and crossed all the t’s. You thought you’d taken every prescribed step.
And still you got a warning letter. What went wrong?
What you may not realize is that FDA scrutiny can probe every aspect of your operation — customer service, field servicing, sales, device reporting, CAPA, design change, corrections and removals, and more.
You need a systemwide solution — one that turns your entire operation into a well-oiled complaint-handling machine. If you aren’t sure how to pull it off…
Here’s just a sampling of what’s covered in this three-hour video tutorial:
It’s a lot of ground to cover. Many devicemakers — especially smaller ones — have no idea where to start.
Fortunately, your instructor does.
Dan O’Leary, principal of Ombu Enterprises, shares lessons learned in 30 years of work in the quality and operational excellence fields.
This three-hour video presentation brings Mr. O’Leary right into your office to explain the regulatory requirements, both in the U.S. and abroad, and help you integrate all your operations into a cohesive complaint management system.
Here’s what you’ll get:
Why risk a warning letter … or worse … when it’s this easy to take matters in hand? Start whipping your operation into shape.
Dan O’Leary has more than 30 years of experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. Dan is now President of Ombu Enterprises, LLC a consultancy focused on operational excellence and regulatory compliance serving small manufacturing companies. 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 is certified by APICS in Resource Management.
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