On 12 December 2012 the FDA issued a new Draft Guidance for Industry & FDA Staff on Design Considerations (for design and development) for Devices Intended for Home Use. Back in April 2010 the FDA launched the Medical Device Home
FDA Draft Guidance – Human Factors & Usability Engineering
The FDA issued a draft guidance document on ‘Applying Human Factors and Usability Engineering to Medical Devices to Optimize Safety & Effectiveness in Design’ for Industry and FDA Staff as of June 22, 2011. A 90 day comment period is
Two Conf’s on 60601 Series of Stds Mar 3 & 4th
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,
Eisner Safety Consultants Newsletter #6 Now Online
Eisner Safety Consultants Newsletter #6 – published 6/30/2010 & covers Recent news on IEC/EN 60601-1:2005/2006; Classification MedDev, Clinical Data & Usability Analysis Requirements per the Amended MDD; and Rechargeable Batteries with Inductive Coupling Download all our newsletters at http://www.EisnerSafety.com/esc-news/