R&Q Resources

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culture of quality, quality

A Culture of Quality

As quality professionals, we are always looking for ways to improve the quality..


Medical Devices, Reliability, Use Case, HALT, quality

Reliability – From Bike Racks to Medical Devices

Every once in a while, when I’m not running, I like to take my bike down to the..

best practices, Quality System, autonomy, Guidance Document, Innovation, regulatory, improvements, quality

Autonomy with Boundaries

I have a teenager that just passed his Driver’s Test. As he pulls out of our..

quality management, FDA, medical device, 21 cfr 820, Joseph Juran, quality, iso 13485

Architect of Quality - Part 1

Have you ever wondered where quality management systems came from, or why these..

Biocompatibility, mobile medical applications, Precedence, FDA, Substantial Equivalence, regulatory, 510(k), quality

Setting Precedence

I sat down tonight, as I do every night that I write a blog post, and I started..

quality systems, production quality, design quality, China, FDA, medical device, regulatory, quality

International Spotlight - China

When people ask my opinion of the most difficult country to register medical..