Eisner Safety Consultants

  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, and the impact of change on industry Usability and Human Factors verification, validation, and regulatory [...]

Topic: “Make sense of the IEC 60601-1-11 standard” The Medical Electrical Device Collateral Standard in the Home Healthcare Environment Presenters: Leo Eisner of Eisner Safety Consultants will be co-presenting with Joseph Murnane of Underwriters Laboratories When: Feb 10, 2011 (Thursday) Where: Anaheim Convention Center while you are at the MD&M West Conference What’s it about: [...]

A New Work Item Proposal for Medical Electrical Equipment & Medical Electrical Systems used in the Emergency Medical Services Environment will be submitted to ISO by the end of November 2010.  This proposed standard follows the structure of the Collateral Standard IEC 60601-1-11 Medical Equipment and Medical Systems for Home Use that was published April 2010. [...]

How to comment on FDA CDRH FY11 Draft Guidance Documents?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 CDRH is considering for development this year (2011). CDRH plans to update this list every [...]

BS EN 60601-1-11:2010 Medical electrical equipment-Collateral standard for use in home healthcare environ Pub 31-JUL-10 http://ht.ly/2fRwW