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How Comment on FDA CDRH FY11 Draft Guidance Documents?
How to comment on FDA CDRH FY11 Draft Guidance Documents?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
IEC 60601-1-11, 1st ed. published Std for Med Elec Equip & Systems used in Home Healthcare Environ
IEC 60601-1-11, 1st edition, just published Apr 28, 2010. This is the Medical electrical equipment collateral Standard for Medical electrical equipment & systems used in home healthcare environments.
Should Medical Apps Face Government Oversight?
Should Medical Apps Face Government Oversight?: Scientific American Apr 12 ’10 http://ow.ly/1yViv
FDA Requires Manufacturers to Include Info on Pediatric Populations
FDA Requires Device Manufacturers to Include Information on Pediatric Populations http://ow.ly/1vJpz