Eisner Safety Consultants: Qmed Qualified Supplier
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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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Standards Reconnaissance Service Coming Mid Oct ‘15 to Eisner Safety Consultants






Do you want to ensure standards compliance to meet quality & regulatory requirements? Compliance to standards has become a key part of regulatory requirements. Due to move towards Global Harmonization of regulations, it has become important not only for the developed markets of US, EU, etc. but also the emerging markets (e.g. China, Brazil, etc.) Our […]

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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.