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.
Order Your Copy Today!
(Add $10 shipping and handling per DVD for DVDs shipped to the US, or $35 per DVD for DVDs shipped elsewhere. VA residents, please add 6 percent sales tax.)
Meet the Instructor
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.
Your risk is zero when you purchase under our money-back guarantee. Not satisfied with the Secrets of Medical Device Complaint Management DVD return it within 30 days (in reasonable condition) for a 100 percent refund of your purchase price (less shipping/handling).
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