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Tag: medical device testing standard

Does your company manufacture or market medical devices in the European Union? Then you’re probably aware of the upcoming implementation of the EU Medical Device Regulations in May of 2020. And for IVD manufacturers, the new In Vitro Diagnostics Regulation goes into effect May of 2022. But whether you have four months or two years to prepare, you must be educated on the new regulations, which will modernize the processes by which medical devices and IVDs come to market.

Published in MultiPoint Blog

In the past several years, many changes have been made to the regulations and rules governing the medical device industry—and there are still more to come。

While regulatory changes are not entirely worrisome to larger manufacturing companies, smaller companies who have fewer funds and resources often find it difficult to adapt to regulatory changes. As new and revised regulatory standards loom before us, it is in these smaller companies’ best interests to prepare for the coming changes.

Mexico's medical device market regulator, COFEPRIS, recently added 573 items to its not considered medical devices, effectively removing registration as a requirement for importation, distribution or sale of these products in Mexico。 Most of the products added to the no-registration list share low-risk profiles, or are components or accessories to other medical devices。 Most notably, standalone software remains on the list of products not required to be registered with COFEPRIS。

Please contact Rhein Tech Laboratories, Inc。 at 703。689。0368 or sales @ rheintech。com for additional information。 

Published in MultiPoint Blog

EU - New Amendment to EN 60601:2006

Posted on February 27th 2020

CENELEC recently ratified a new Amendment to EN60601:2006. The new Amendment (EN 60601-1:2006/A1:2013) includes the all elements from EN 60601-1:2006/A1:2012 with additional detail explaining how essential requirements in the Medical Device Directive (MDD) are covered via clauses in the EN60601-1 Standard or by other Standards. The new Amendment will go into effect upon it's date of publication - June 24, 2014.

 

 

The US Food and Drug Administration has extended their deadline for IEC 60601-1 3rd Edition medical device electrical standard compliance to December 31, 2013.

Published in MultiPoint Blog

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