RQM+ Medical Device and In Vitro Diagnostic Blog

on 7 September 2016 | By Carol Vierling

This article was originally published in Summer of 2016's Made in PA issue, a publication of the Pittsburgh Technology Council. The competitive landscape of medical devices combined with the advantages of being first to market often tempt manufacturers to move through the...

on 22 June 2016 | By Stephen Biernacki

About R&Q's Case Studies: We hope you enjoy our latest case study. View all of our available Case Studies. Subscribing to our blog is the best way to know when future case studies are available. FDA Approved: Creating and Implementing a Compliant Usability Engineering Process...

on 4 May 2016 | By Kate Keverline

Attention any and all regulatory affairs specialists, engineering managers, quality & production engineers, QA/Q directors and managers and compliance officers: AdvaMed is presenting a Design Control-focused workshop in Golden Valley, Minnesota, June 7-8. The workshop has been...

on 16 April 2013 | By Ryan Kasun

Recently I had to get my annual mammogram. They were running behind like doctor’s offices sometimes do - there were seven women in dressing gowns in the waiting room with me. After a few awkward moments, we all started to talk to each other. Every single one of the ladies talked...

on 10 April 2013 | By Ryan Kasun

If you’ve ever spent any appreciable amount of time in a hospital or other medical care facility, you may have been driven temporarily insane by the never-ending chorus of medical device alarms. I was recently reminded of a few nights I spent in the hospital with my dad a year...

on 14 November 2012 | By Ryan Kasun

Several years ago a good friend who knows my interest in human factors and engineering psychology gave me a book called Set Phasers on Stun and Other True Tales of Design, Technology, and Human Error, by Steven Casey. I started to read it again recently and wanted to share it...