Newsletter Put Out BY Medical Device Manufacturers

FDA Adverse Event Information, Medical Device Approval Process, and FDA Corruption

Newsletter Put Out BY Medical Device Manufacturers

PostPosted by DCNGA » Mon Sep 12, 2011 11:59 am

I subscribe to a medical device manufacturer's news letter.

This one came today. I've bolded interesting information.

FDA says approximately 44% of device recalls are due to faulty design.

Recalls are expensive, embarrassing, and often lead to more serious financial consequences — not only from FDA but also from courts and unhappy shareholders.

Stop spinning your wheels with nonessential activities that waste time and money. To survive in today's tough economy and ultra-competitive medical device market, you need a Quality System that works from the get-go — from the start of product design continuing through component selection, manufacturing, use and disposal.

Register now for Medical Device Compliance Institute 2011: Quality Systems and Design Control Training — two courses presented by EduQuest in cooperation with FDAnews that are offered separately or as an integrated three-and-a-half-day learning package — and learn how to develop a by-the-book quality management program. Leave the guessing to your competitors.

Discover how to overcome one of the biggest obstacles device manufacturers face — how the FDA expects you to develop and implement design controls, then transfer product design to manufacturing operations.

With three-and-a-half days of intensive training you'll walk away with the compliance guidance and insight you need to meet FDA standards with confidence.

Learn straight from the source — former FDA inspectors, rule-makers, and trainers from the global consulting team of EduQuest, headquartered near Washington, DC. Your instructors include one of the co-authors and trainers of FDA's Quality System Inspection Technique (QSIT) and the founding editor and co-author of FDA's "bible" for inspectors, the Investigations Operations Manual (IOM).

Through plain-English instruction, detailed course materials, and interactive exercises that reinforce the lessons (not to mention making the classroom more fun and interesting), you'll learn to cost-effectively comply with the FDA's QSR rules and related international standards.

Specifically targeted to device manufacturers and suppliers, now you can gain a thorough understanding of the massive 21 CFR 820 Quality Systems Regulation requirements. Know what it takes to stay in compliance and avoid the risk of your product not getting to market or being removed from the market once it's there.
"It is a good thing to learn caution from the misfortunes of others."

"If you wish to succeed in life, make perseverance your bosom friend, experience your wise counselor, caution your elder brother, and hope your guardian genius."
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