AssurX Blog
Straight talk for regulated industries.
Why Calibration Management Software is Key to Proactive Quality
Unplanned downtime is an expensive issue, costing companies $50 billion every year, according to research by IndustryWeek and Emerson. Nearly half of this downtime is the result of equ [...]
EU Medical Device Regulation Still Presents Challenges and Opportunities
EU Medical Device Regulation (MDR) has been in effect for almost a year. As anticipated, the regulation has proven to be as challenging as the industry expected it would be. Now, compa [...]
Food Industry FSVP Violations Revealed in FDA Warning Letters
In recent months, the U.S. Food and Drug Administration (FDA) has issued a dozen warning letters over Foreign Supplier Verification Program (FSVP) violations. These food industry FSVP [...]
How to Overcome Quality Management Review Challenges
This is the second installment of a two-part series focusing on the importance of a quality management review for companies in regulated industries. One of the most important parts of [...]
What is a Quality Management Review and Why Do You Need Them?
This is the first installment of a two-part series focusing on the importance of a quality management review for companies in regulated industries. What is a quality management review [...]
Understanding FDA Alignment of ISO 13485 with Quality System Regulation
The FDA’s official proposal to align its Quality System Regulation (QSR) with ISO 13485:2016 was long in coming, but worth the wait. Regulatory authorities consider it necessary to imp [...]
