Standards
Aug 15, 2012
Today, manufacturers routinely conduct summative (i.e., validation) usability tests to determine if their medical devices are safe to use “as is,”...
Feb 22, 2012
The intersection of mobile health technologies with medical devices is an increasingly hot topic, but there is also confusion and frustration felt by some in...
Jul 28, 2011
A series of digital force gauges is designed for conducting tension and compression force testing in QC, manufacturing, and R&D departments. Series 3 is...
May 04, 2011
For all of the aseptic technical details and analytical thinking that goes into developing medical devices, it’s a fundamentally human enterprise. Humans...
Apr 27, 2011
Collateral Standards The general requirements of 60601-1 apply to all medical electrical equipment and part 2 standards apply to specific categories of medical...
Apr 27, 2011
Although the transition period for the third edition of the medical electrical equipment standard (IEC 60601-1:2005) doesn’t end until 2012, there are...
Apr 14, 2011
Certification bodies like UL have learned that medical device manufactures require more assistance and knowledge as the multiple global market access...
Jan 05, 2011
I’m terrified of something coming in 2012. No, I’m not talking about the end of the Mayan calendar, but what I am afraid of is something that will...
Jan 04, 2011
Medical device manufacturers and their customers are required to implement design standards that incorporate patient-centric human factors, including...
Dec 15, 2010
A series of meetings were held recently to sort out a whole succession of connector standards. The meetings took place over a period of two weeks in Seattle....