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,
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
AAMI News: Online Med Dvc Stan…
AAMI News: Online Med Dvc Standards Portal Access to Over 2,000 Std’s & Reg’s (AAMI, ANSI, ASTM, DIN, IEC/ISO, FDA) http://ow.ly/1n2Jg
Eisner Safety Consultants Newsletter #1 Available
ESC Newsletter #1 – Just Released This newsletter contains articles on IEC 60601-1, 3rd ed (published in MD&DI – Sept ’09), The Amendment to the Medical Device Directive, Pre-Announcement of our Gap Analysis & Update Package for the MDD Amendment