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EU MDR & IVDR Have Been Published in OJEU 5 May 2017

Update of May 5 2017 Addition of the Published Documents “EU MDR & IVDR were  Published in OJEU TODAY Friday May 5, 2017″ Stop the Presses and add these earth shattering Regulations to your reading list for the next week or two: Medical Device Regulation (EU) 2017/745 and In Vitro Diagnostic Regulation (EU) 2017/746 Bassil Akra of TÜV SÜD […]

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Save $20K or more with ESC’s Annual Standards Trends Reports

Eisner Safety Consultants’ Annual Standards Trend Reports can save you time and money by: Reducing the amount of time needed to put your list of Current Standards together for your Quality System Having an early warning system in place to be able to strategically plan your product development (in some cases you may need to redesign & […]

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Global Medical Device Regulatory & Standards Updates

Enjoy our Second global standards & regulatory update.  It provides you with tools to help strategically plan for regulatory & standards updates for the Medical Device Industry Let’s start with some really big news!!! It is anticipated in 2019 IEC 60601-1 edition 3 + Amendment 2 will be published & around 2024 we anticipate that 4th ed. of […]

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World-Wide Medical Device Regulatory & Standards Updates

Special global update post that gives you tools to help strategically plan for regulatory, & standards updates for the Medical Device Industry For this special posting I thought we should travel the world & provide you with a great deal of valuable information to help you on your product development way, including regulatory support, standards […]

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Standards Reconnaissance Subscription Service Coming Soon

Does your Medical Device Regulator or your Quality System require that you maintain a list of applicable standards to meet these requirements for your product lines?  How much time does it take to put this list together and how much effort does it take to keep the list updated? If this is a struggle for […]