Come join Eisner Safety Consultants at one or both conferences March 3 & 4th. Both are related to the 60601 series of standards. On March 3rd join FX Conferences and Leo Eisner to learn about the home healthcare environment and
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 Modifications to List of Recognized Standards, List 025
On Oct 4, 2010 the Federal Register published the “Modifications to the List of Recognized Standards, Recognition List Number: 025“. This list will assist medical device manufacturers who elect to declare conformity with FDA Consensus Standards to meet certain FDA
Federal Register: Comprehensive List of FDA Guidance Doc’s
Federal Register Comprehensive List of FDA Guidance Documents; Notice http://ht.ly/2nKfg
FDA Guidance & Fed Reg – FY 2011 Med Dvc User Fee Rates
FDA Guidance Fiscal Year 2011 Medical Device User Fee Small Business Qualification & Certification http://ht.ly/2nHdQ & Federal Register Medical Device User Fee Rates Fiscal Year 2011 http://ht.ly/2nHgX