Eisner Safety Consultants: Qmed Qualified Supplier
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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 […]

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EN60601-1:2006 + A1:2013 Has Been Harmonized Under the MDD

This post discusses that EN60601-1:2006+Amendment 1 (A1):2013 has finally been Harmonized under the MDD. This is really big news that many of us in the medical industry have been waiting to hear occur for quite awhile. What’s The Big News About? On 16 May 2014 the Official Journal of the European Union (OJEU) published an […]

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Status Update on EN 60601-1:06 + A1:13 for EU MDD & Annexes ZA & ZZ

EN 60601-1 (2006) + A1 (2013) status for EU MDD Harmonization & Impact of Annex ZA & ZZ are discussed in this blog.

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Where is EU headed with Proposed Medical Device Regulations by ENVI?

The answer seems to be in the direction of a US FDA Style review process for some higher class devices (Class IIb & III) which means longer time to market and more hurdles to get past for these types of devices.  Note, this issue is not set in stone and you should read some of the […]

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Great Resource – Current/Draft IEC 60601/80601 Series of Stds & Test Rprts Now Available

We recently updated our website to make it easier for you to check the current IEC 60601 standards and the test report forms (TRFs) and you can check the status of draft standards and where in the process they are.