Good News!
On behalf of the entire ASQ Medical Device Division leadership, we are sorry for the issues with logging into the Oct. 17 Webinar "FDA Quality Management SYSTEM Regulation: How Should You Prepare?"
We contacted Cisco WebEx support and due to updates to their default security settings for our WebEx account, there were issues connecting to our webinar from a PC. We now know why the issue happened and how to prevent it.
Additionally, we have contacted the speaker Tim Gooch, and he has agreed to present the Webinar again, on November 16th at 6:30pm Central Standard Time. We would LOVE for both those that had issues logging in and those that couldn’t attend to join us.
Thank you for your patience. We understand how frustrating the situation was and are doing everything we can to make it right. Medical Device Division Leadership continues to work hard so we can bring you excellent and topical content. Please don't hesitate to contact us. You are also welcome to join our monthly division meeting (3rd Monday of month at 7pm US central) to help us serve you.
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Are you ready? U.S. Food and Drug Administration to Adopt ISO 13485 - webinar
On February 23, 2022, the United States Food and Drug Administration proposed an amendment to 21 CFR 4 and 820. The purpose of the proposed change is to better align the agency’s medical device quality management system requirements with the international consensus standard for devices, ISO 13485: 2016 (the Standard), used by other regulatory authorities. This will affect quality management system (QMS) requirements for both medical devices and combination products involving both medical devices and drugs.
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Tim Gooch
- Technical Director, Knowledge at SGS
- Life Sciences Management Systems and Supply Chain
- Tim has over 40 years of experience in Medical Devices, including design and development for neck and above surgical implants, active implantable devices, and audiological active devices. He has served in the testing, inspection, and certification business since 2012 including Global Manager for MDSAP at SGS. His current role as technical director includes quality system certifications for medical devices, cosmetics, and pharmaceuticals.
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