On January 14, 2011 NorthWest EMC announced that it is offering SAR (Specific Absorption Rate) evaluations at their Hillsboro Oregon location. They have done a lot of work up front to make sure that their SAR evaluation equipment is accredited to
Health Canada Revised Significant Change Interpretation Guidance Doc
On January 20, 2011 Health Canada issued a notice in regard to the “Guidance for the Interpretation of Significant Change of a Medical Device”. This newly released guidance document replaces the previous 2003 guidance document. The date of revision for
Leo Eisner Presenting at RAPS/ASQ on IEC60601-1 3rd ed.
Biomedical Division Northern California Discussion Group andSan Francisco Bay Area Chapter Topic: “Evolving Risk-Based Regulatory Requirements” whole day workshop covering 3 key quality & regulatory areas: IEC 60601-1, 3rd ed. general, collateral, and particular standards including essential performance, risk management integration,
FDA Updates 515 Prog. Initiative Webpage (reclassified preAmend Class III 510(k)s)
The FDA updated the 515 program initiative webpage also known as reclassification of preAmendment Class III 510(k)s. Currently there are 26 Class III products going thru the 515 program initiative and you can view the status of the 515 project.
FDA 510(k) changes announcement Jan 19 2011 from MassDevice
MassDevice online article 1/19/2011 – The FDA 510(k) changes are to be announced today, Jan 19 2011. http://ht.ly/3Gz2O
