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Clear, actionable intelligence for regulated industries.
Expert perspectives that simplify complexity and support stronger quality and compliance outcomes.
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 IndustryWee [...]
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 [...]
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 V [...]
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 compa [...]
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 compani [...]
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 wor [...]
