Eisner Safety Consultants: Qmed Qualified Supplier
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FDA Draft Guidance – Info to Support a Claim of EMC for Medical Devices






On 2 Nov 2015 FDA issued a draft Guidance document titled: “Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices”.  The Guidance was developed to describe the types of information that the FDA expects to be provided in a premarket submission to support a claim of Electromagnetic compatibility (EMC) for electrically-powered […]

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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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FDA Updates Guidance on Device Classes Exemptions from Premarket Notifications Requirements






This post covers 8 product codes added & updates made to the guidance on Device Classes Exemptions from Premarket Notifications Requirements On Aug 14, 2015 FDA updated the Final Guidance Document titled “Intent to Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices from Premarket Notification Requirements”.  It was originally issued as a […]

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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.  

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IEC 60601-1, 3rd ed. related standards changes & new Interpretation Sheet 3






IEC 60601-1, 3rd ed. has been out for about 7 years now and there have been lots of changes within the IEC 60601 series of standards to align with 3rd edition.