RQM+ Medical Device and In Vitro Diagnostic Blog

on 27 July 2017 | By Stephen Biernacki

On May 5, 2017 the EU MDR (Medical Device Regulation) was published in the EU Official Journal. This date starts the three-year mandatory transition period where the MDR will replace the MDD (Medical Device Directive). The expanded scope of the MDR combined with the time frames...

on 19 February 2013 | By Ryan Kasun

Up until the time when I joined the RQS team in November all I had ever truly worked on was Quality. Coming out of college I worked for a plastics bottling manufacturer in process development and quality control. My next job was design V&V closely followed by design quality...

on 21 January 2013 | By Ryan Kasun

I constantly find myself trying to draw parallels between my work life and personal life in almost everything I do and while I work in Quality and Regulatory for medical device manufacturers, I enjoy spending downtime playing fantasy football. Being that this weekend was the...

on 17 December 2012 | By Ryan Kasun

During this holiday season, when presents are being packaged and shipped at high volumes, I thought it would be appropriate to talk about the importance of labeling.