There will be an FDA Town Hall meeting on March 10, 2011 with the Director of CDRH and with other top management of the CDRH. The meeting will be held at the Irving Convention Center at Las Colinas, 500 West
Meet Leo Eisner at MD&M West Feb 7 – 10, ’11
I would be happy to meet up with you if you are interested in our services at Eisner Safety Consultants or would like to learn more about us. Also, if you are one of our clients let’s set-up a time
NW EMC Now Offering SAR Evaluations
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,