Design Control for Medical Devices

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The experts who offer the FDA Compliance Boot Camp are now adding an intensive medical device training course.

The 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 the 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 Design Control for Medical Devices: Meeting FDA’s 21 CFR 820.30 Rules for Quality Design and Manufacturing — presented by EduQuest in cooperation with FDAnews — 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 two 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 instructor is the founding editor and co-author of the FDA's "bible" for inspectors, the Investigations Operations Manual (IOM). Your instructor also served on FDA’s Design Control Inspection Strategy team, giving you even more insights into the Agency’s approach to evaluating your Design History Files, Design Master Records, and more.

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Design Control for Medical Devices: Meeting the FDA's 21 CFR 820.30 Rules for Quality Design and Manufacturing (16 Course Hours)

Design control is required for all medical devices sold in the U.S., EU, Japan, and several other countries. In addition, there's relentless pressure from both the FDA and Congress to improve device design control and manufacturing.

By registering for the Design Control for Medical Devices, you'll learn how the FDA expects you to develop, implement, and manage design control. You'll also focus on overcoming one of the biggest obstacles that regularly confounds device companies — accurate and consistent transfer of product design to actual manufacturing operations. Moreover, you'll learn how the FDA's design control rules relate to product quality standards established in ISO 9001:2008 and ISO 13485.

Click here for the full agenda.

Deploy an arsenal of compliance knowledge and rank at the top at your next FDA visit.

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Get two days of hands-on, interactive training! Course instructors have trained the FDA's own investigators — and some are former FDA investigators themselves.


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