Eisner Safety Consultants

On July 21, 2011 the FDA released a draft Guidance document on Mobile “App’s”.  There is a 90 day period to submit comments for consideration. (See details on web link for draft guidance). The draft guidance document states in section IV: “This guidance explains FDA intentions to apply its regulatory requirements to a subset of [...]

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 the proposed emergency medical services standards, respectively IEC 60601-1-11 & IEC 60601-1-12 (hopefully).  More information [...]

  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 [...]

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 requirements for medical devices.

Federal Register  Comprehensive List of FDA Guidance Documents; Notice http://ht.ly/2nKfg