TechWhirl (TECHWR-L) is a resource for technical writing and technical communications professionals of all experience levels and in all industries to share their experiences and acquire information.
For two decades, technical communicators have turned to TechWhirl to ask and answer questions about the always-changing world of technical communications, such as tools, skills, career paths, methodologies, and emerging industries. The TechWhirl Archives and magazine, created for, by and about technical writers, offer a wealth of knowledge to everyone with an interest in any aspect of technical communications.
There's one more wrinkle in this ASAP project..the FDA!! Maybe this
guidance will help you finesse their review?
> 2. FDA ISSUES GUIDANCE ON ANTICIPATING HUMAN FACTORS IN MEDICAL DEVICE USE
> The Food and Drug Administration ("FDA") released guidance on July 18
> that focuses on incorporating human factors engineering into risk management
> in order to reduce hazards related to use of medical devices. The guidance
> emphasizes the importance of identifying specific ways that people might use
> a medical device in order to identify significant device use problems in
> advance.
> To read the FDA's guidance, use our Ask Health Lawyers service at
>http://www.healthlawyers.org/askset.htm.
>
***************************************
"The world we have created today...
has problems which cannot be solved
by thinking the way we thought when
we created them."
...............................Albert Einstein
