RQM+ Medical Device and In Vitro Diagnostic Blog

on 29 May 2024 | By Scott Edwards, Managing Director, RQM+

Most of us are familiar with the fast-paced world of MedTech and the mounting pressures to maintain product quality, safety, and compliance companies face. With the FDA increasing the number of Class I recalls and the EU MDR/IVDR placing greater responsibilities on the Person...

on 7 November 2013 | By Ryan Kasun

As quality professionals, we are always looking for ways to improve the quality of products, and reduce the cost of quality mishaps. But how do you actually climb to the top of that mountain of high quality while still maintaining a marketable product?

on 22 August 2013 | By Ryan Kasun

Every once in a while, when I’m not running, I like to take my bike down to the river trails of downtown Pittsburgh. I throw my bike rack on my car, strap it in, and I’m ready to go. Being as I only used my bike rack about ten times since I got it, I was surprised when I went to...

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 4 March 2013 | By Ryan Kasun

I have a teenager that just passed his Driver’s Test. As he pulls out of our driveway, I see the freedom, the possibilities, the trouble that he could get into. Although a bit poetic and a bit melancholy, it’s also a bit exciting. His father and I cautiously trust him – he’s a...

on 13 December 2012 | By Ryan Kasun

I sat down tonight, as I do every night that I write a blog post, and I started reading the prior posts from my colleagues. I had every intention of writing on a different topic tonight, but something struck a chord with me when I looked through the blogs. They all had something...

on 29 November 2012 | By Ryan Kasun

When people ask my opinion of the most difficult country to register medical devices internationally, I would have to say it is China. China is considered to be an “emerging market”- it is getting more and more lucrative to register there as the population gets larger and...