RQM+ Medical Device and In Vitro Diagnostic Blog

on 9 March 2023 | By Ryan Kasun

Recently, I had the opportunity to attend a Risk Management Conference hosted by the FDAnews. At the beginning of the conference, we all went around the room and introduced ourselves, and indicated why we were there. Not surprisingly, a majority of people were there to have a...

on 28 April 2021 | By Chad Quistad, RQM+

As the underlying risk management process for medical devices, the ISO 14971 standard is a critical component of regulatory and quality compliance. When new versions are released and harmonized, it’s up to manufacturers to learn about the changes to update systems accordingly....

on 5 September 2013 | By Ryan Kasun

On the news this morning, I heard a story that got me thinking about risk management. The headline was “Eight N.H. patients possibly exposed to fatal brain disease”. Further research about the situation reveals just how complex this case is.

on 3 April 2013 | By Ryan Kasun

As a somewhat rabid hockey fan there are a few days during the year that are considered sacred holidays: every playoff game, first day of free agency, and the trade deadline. My mind is on hockey because the trade deadline happens to be today. Outside of my insatiable desire to...

on 7 February 2013 | By Ryan Kasun

You may have heard that last year there were two new releases of EN standards: EN ISO 14971:2012 and EN ISO 13485:2012. What does this mean to you? What are the changes? How much does this affect the way you do business? Compliance to standards can be somewhat overwhelming....