Blog focus BSI’s 7th in a series of White Papers for Medical Device, on Human Factors & Usability Engineering White Paper on The growing role of human factors and usability engineering for medical devices This white paper is on “The growing role
2013 RAPS Regulatory Conf. Presentation – IEC60601-1 3rd ed., Managing Human Factors & Usability Risks
Join us at the 2013 RAPS Regulatory Convergence Conference (Boston) in the Medical Device Track on IEC 60601-1 Third edition: Managing Human Factors and Usability Risks. Your experts that will help you through these issues are Leo Eisner of Eisner
Presentation on Navigating FDA’s Home Use Medical Devices Draft Guidance
Leo Eisner will be presenting on the topic “Navigating FDA’s Draft Guidance on Home Use Medical Devices” at an FX Conferences event on 11 July, 2013 (Thurs) at 11:00AM – Noon (Pacific), 2:00PM – 3:00PM (Eastern). You don’t have to
New LinkedIn Group on IEC 60601 Medical Electrical Equipment & Systems
A new LinkedIn group has been formed thx to the support of the IEC (International Electrotechnical Commission)*. The group name is the IEC 60601 series of standards on Medical Electrical Equipment. This group is not just about the 3rd edition
FDA on Quest to Standardize Mandatory MedDvc Labeling
On 4 Jan 2013 the FDA issued, in the Federal Register, a notice of Public Workshop entitled “Accessible Standardized Medical Device Labeling”. FDA indicated the focus of the workshop is to “discuss the growing need for medical device labeling to be