The FDA’s Home Use Draft Guidance Document has drawn a lot of attention since it was published on 12 Dec 2012. The article that the Medical Electronic Device Solutions (MEDS) Trade Publication released on February 2013 is titled FDA Issues Draft
MD&DI Articles on Home Use FDA Draft Guidance & Be Aware
This post deals with the FDA’s Draft Guidance on Home Use Devices. But it is a two for one (two articles and a note from Leo Eisner about the draft guidance to be aware of so really a 3 for
Tracking Vital Signs, Without the Wires
In the New York Times on Sept 3, 2011 – The article starts ‘CONFINED to their hospital beds, patients can only fantasize about stripping off all the wires that connect them to monitors and bolting for the door…’
Conf. on IEC 60601-1-11 & Proposed IEC 60601-1-12 (Home Health Care & Emerg Med Srvcs Environ Stds)
Topic: “Implications of the Electro-medical Standards IEC 60601-1-11:2010 & Proposed IEC 60601-1-12” The Medical Electrical Device Collateral Standards in the Home Healthcare Environment and the Proposed Emergency Medical Services Environment, respectively Presenter: Leo Eisner of Eisner Safety Consultants When: March