From MDDI Magazine – Sept 2010 – “FDA has released its long-awaited plans to shore up the 510(k) clearance system used to get many medical devices to market. In August, the agency published a 120-page report to define which devices
Proposed Rules for Li Batteries Will Cause Serious Impact
By Rose Electronics – Oct 2010 – The Department of Transportation has proposed new regulations for air shipment of lithium batteries that would designate small lithium batteries and cells as Class 9 materials to be handled as potentially hazardous. Only
ESC @ 74th IEC Gen. Mtg til Oct 16 ’10 – Med Elec Equip Comm’s TC62, SC 62A & 62D
Eisner Safety Consultants is attending the 74th Annual IEC General Meeting in Seattle Washington thru Oct 16, 2010. As a US National Committee member of Technical Committee (TC) 62, Subcommittees (SC) 62A & 62D we are attending the committee meetings
How Comment on FDA CDRH FY11 Draft Guidance Documents?
How to comment on FDA CDRH FY11 Draft Guidance Documents? http://ht.ly/2OiXg From the FDA CDRH webpage titled “Documents the CDRH is Considering for Development (FY11)” the following is the intoduction to the page: “This is the list of guidance documents
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Have you signed up for our newsletters? Full of vital Medical Dvc Regulatory, Compliance, & Quality Systems info http://ht.ly/2Cs0V
