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Tag: medical device testing

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.

Testing electrical and electronic devices for EMC compliance can be a daunting task. With few local testing labs available, companies will often have to travel to find a certified testing lab that is equipped to assess their specific product. And due to the lack of available labs, companies often have to book testing sessions in advance and follow an unforgiving, strict schedule. The thought of EMC testing gives engineers a headache, but the thought of failing testing and having to repeat the process a second or third time is even more frustrating. For medical device engineers, whose standards are much stricter than other device standards, testing for EMC compliance is a bit of a nightmare. There is, however, a way to speed up the process of EMC testing while keeping costs low: prescreening devices for EMC compliance.

Published in MultiPoint Blog

In the age of IoT and AI, many are now wondering if the standards that govern innovative industries, such as the technology and medical device industries, are stifling innovation。 According to a 2017 study, , in markets with both low and high uncertainty, businesses that experience problems with standards have to spend a larger amount of resources to be innovative。 Many manufacturers, however, don't end up marketing their products because they cannot pass compliance with regulatory bodies and do not possess the resources to re-test and redesign products。 This poses a significant threat to the global economy as well as to technological evolution。      

Published in MultiPoint Blog

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 @ hfytxx.com for additional information. 

Published in MultiPoint Blog

Medical Device Data Systems (MDDS), used to support digital health technologies, are no longer subject to FDA regulation per a new FDA guidance。 Specific MDDS devices include:

  • MDDS falling under 21 CFR 880.6310
  • Medical image storage devices under 21 CFT 892.2010
  • Medical image communications devices under 21 CFR 892.2020

The FDA does not intend to enforce compliance for devices subject to the three regulations listed above in terms of registration and listing, premarket review, post-market reporting and FDA Good Manufacturing Practice quality system requirements.
The new FDA draft guidance also changes the agency's approach to regulating mobile medical apps and technologies where MDDS is concerned. Sections V-A-1 and V-B as well as Appendices B, C and D of the FDA's Mobile Medical Applications guidance have been amended to exclude MDDS, medical image storage and medical image communication devices from the scope of the agency's regulatory remit.

斗地主达人Please contact Rhein Tech directly if you have additional questions or require testing and certification assistance.  703.689.0368

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.



Published in MultiPoint Blog

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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