Continual Improvement, LLC

In May of 2017 the EU passed its revised Medical Device Regulations (MDR) and InVitro Device Regulations (IVDR).

Create a system that doesn’t need last minute “cleanup for the auditor.”

In our COVID-19 alternate reality, most businesses are running at some level.  As a certifying body, we at PQA have a unique insight on...

A QMS is a set of frequently-updated controlled documents that define what you do and how you do it in your business.

Part of any quality management system (QMS) is checking to see if you are really doing what you claim.

Being compliant, but not certified, is like going through college but never taking the exams to prove you learned anything.

ISO 14001 is a standard companies use to certify their businesses have made a commitment to reducing the company's impact on the environment

ISO 13485 takes the core quality management concepts of ISO 9001:2008 and adapts them to the medical device industry.

The concept of ISO 9001 certification can seem overwhelming. But the truth is, ISO 9001 is really just good business practices written down.

What do you think of when asked if you do design--engineers? Original concept development? What about processes development?