RQM+ Medical Device and In Vitro Diagnostic Blog

on 31 March 2025 | By Catherine Kang, RQM+ Senior Principal

Navigating fertility treatments can be a physically and emotionally demanding experience for women. As the sole child bearers, women are more directly impacted by procedures like in vitro fertilization (IVF), which require a significant toll on their bodies even before pregnancy...

on 14 January 2016 | By Stephen Biernacki

Organizer Us! Regulatory and Quality Solutions (R&Q) What? A presentation and networking event over lunch addressing how an accessory or tool, in reality, is often a medical device. This session will discuss combination products and the use of accessories with drugs and...

on 31 January 2013 | By Ryan Kasun

On January 18, 2013, the FDA announced their final rule on current good manufacturing practices for Combination products. These Guidance Documents will tell companies when submissions would be required for any post-approval changes to a combination product. First off, what are...

on 30 January 2013 | By Ryan Kasun

Last week, the FDA issued a final rule(1-2) on combination products(3) and the applicable current good manufacturing practice (CGMP) requirements. The final rule actualizes the proposed rule that was issued many moons ago, in September 2009 without significant changes. Four...

on 15 November 2012 | By Ryan Kasun

I have to admit, school doesn't teach you everything. During my first week at RQS, I was working with a client, and we were discussing labeling. She said I needed to get the bomb. Then, if I explode the bomb, everything will be good, and I'll have what I need. I left her office...