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Inspections Summit Preview: Recertification Audits - Don’t Let Your Devices Lose Their CE Mark
Having your facility certified to produce medical devices for sale in Europe is only the first step. Regulations newly in force say your Notified Body must audit you at least once every three years, and these audits will focus less on the facility and more on the devices themselves. These audits are unannounced and, depending on your size, could take anywhere from a few days to several weeks. If you fail one, you’ll be at risk of having your devices lose their CE mark, meaning you’ll be barred from selling them in the EU until the problem is corrected.
Do you know…
If you can’t give a confident “yes!” to every one of those questions, Roberta Goode’s webinar will provide the answers you need. Don’t risk having costly obstacles come between your devices and the European market.
President and CEO, Goode Compliance International
Roberta Goode is an executive with over 25 years of experience in the medical device industry. She is currently President and CEO of Goode Compliance International (GCI), a global leader in engineering and compliance services for medical device manufacturers, specializing in process validation, design control, and risk management. Prior to founding GCI in 2002, Ms. Goode held positions of increasing responsibility in R&D, Manufacturing, and Quality Engineering at Beckman-Coulter Corporation, Althin Medical, Inc. (acquired by Baxter Healthcare), and Cordis Corporation (a Johnson & Johnson company), where she contributed intellectual property in the form of four U.S. patents for percutaneous cardiovascular interventional devices. She holds a Master of Science degree in Biomedical Engineering and a Bachelor of Science degree from the University of Miami. Additionally, Ms. Goode has an adjunct faculty appointment at the University of Miami’s College of Engineering and is an ASQ Certified Quality Engineer.
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