This post deals with the FDA’s Draft Guidance on Home Use Devices. But it is a two for one (two articles and a note from Leo Eisner about the draft guidance to be aware of so really a 3 for
AAMINews on IEC60601-1 Amendment 1
AAMI News: Jan 2013: Excellent Article on Amendment 1 (A1) to IEC 60601-1 Underscores Role of Safety in Device Design.
Proposed Changes to EU Data Protection Directive – May Impact Device Design
Erik Vollebregt, of the law firm Axon Lawyers, has written a very insightful blog post on the recent developments of changes to come down the line for the EU Data Protection Directive and it looks likely that it will turn
Root Cause vs “Systemic” Root Cause
(Post updated on 24 Jan 2013 for those that couldn’t access the LinkedIn Group, refer to 3rd paragraph below) Robert Packard, who is one of the managers of the LinkedIn Group “Medical Devices: QA/RA”, wrote recently on a subject that
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