FDAnews Announces — Latest ISO Medical Device Developments: Real-World Impact on Regulatory, Quality & Compliance Specialists Webinar, May 28, 2020

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A quality management system must keep up with changing international standards. Ensure compliance.

WCG FDAnews

WCG FDAnews

Latest ISO Medical Device Developments
Real-World Impact on Regulatory, Quality & Compliance Specialists
An FDAnews Webinar
Thursday, May 28, 2020, 11:00 a.m.-12:30 p.m. EDT
https://www.fdanews.com/isodevelopments

A quality management system (QMS) should reflect the latest regulatory developments and shifting international standards.

ISO 13485 is being adopted by the FDA (replacing 21 CFR 820 later this year) and incorporated into the EU’s medical device single audit program (MDSAP), among other wide-ranging changes.

Master the interrelationship between these initiatives and the future direction of QMS requirements for a device to ensure compliance and maintain a competitive edge.

Eamonn Hoxey, a technical author, trainer and consultant in life science, will make clear:

•The status of FDA’s adoption of ISO 13485 in place of 21 CFR 820
•The relationship between ISO 13485 and 21 CFR 820
•The relationship between ISO 13485 and the EU MDR requirements
•Implications of the reconfirmation of ISO 13485:2016 on QMS requirements for medical devices
•How ISO 13485 is used in MDSAP
•The future direction of generic management system requirements such as ISO 9001

Understand the changing landscape of ISO medical device developments in order to develop or update one’s QMS.

Interested in registering multiple sites?
Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally
to learn about our special multisite discount.

Webinar Details:
Latest ISO Medical Device Developments
Real-World Impact on Regulatory, Quality & Compliance Specialists
An FDAnews Webinar
Thursday, May 28, 2020, 11:00 a.m.-12:30 p.m. EDT
https://www.fdanews.com/isodevelopments

Tuition:
$287 per site

Easy Ways to Register:
Online: https://www.fdanews.com/isodevelopments
By phone: 888.838.5578 or 703.538.7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations

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Michelle Butler
FDAnews
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