Toxic Substances Control Act Awareness

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vtsiri

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Toxic Substances Control Act 8(c) and 8(e) Awareness for Employees

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WATCH the recorded webinar here: http://www.emergogroup.com/resources/video-webinar-europe-mdr-changes The first major revision to device regulations since 2007 has been released and the changes are significant. Although the MDR won't take effect until early 2020, smart companies are planning ahead to beat the crush of companies that will inevitably wait until the last minute, overwhelming EU Notified Bodies. Ronald Boumans, Senior Global Regulatory Consultant for EMERGO (and former IGZ compliance inspector in The Netherlands) outlines the most important changes you need to know in this 35 minute recorded webinar from September 2016. Topics addressed include: How the MDR is organized Scope of the legislation Device classification rules New clinical evaluation requirements UDI and EUDAMED database Adverse event reporting And much more...

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CE Marking is the symbol as shown on the top of this page. The letters "CE" are the abbreviation of French phrase "Conformité Européene" which literally means "European Conformity". The term initially used was "EC Mark" and it was officially replaced by "CE Marking" in the Directive 93/68/EEC in 1993. "CE Marking" is now used in all EU official documents. "CE Mark" is also in use, but it is NOT the official term. For instance, in the Directive 2007/47/ec, of 5 September 2007, amending the directives 90/385/eec, 93/42/eec & 98/8/ec, the term CE Marking appears 9 times whereas CE Mark appears nowhere in the entire 35-page document. CE Marking on a product is a manufacturer's declaration that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislation, in practice by many of the so-called Product Directives.*

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The 3rd Edition of the medical device risk management standard, ISO 14971:2019, and its companion guidance document, ISO TR 24971:2019, will be published by year-end. The new structure of the two documents will be presented so that the manufacturer can determine any changes to the risk management system and possibly the quality system that may be required. These may include simple reference changes in procedures or revision to production and post-production processes that may be required. Presenter Edwin Bills is an international member of the technical committee, ISO TC 210 JWG1, responsible for the revision of the third edition of ISO 14971 risk management standard. TALK TAKEAWAYS: • A detailed look at the new changes to ISO 14971:2019 and ISO TR 24971:2019. • Reasons for the changes to the latest version • How to prepare for the coming changes in the standard This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.

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