AssurX Blog
Straight talk for regulated industries.
EUDAMED Update: What You Need to Know Now
The European Union (EU) Medical Device Regulation (MDR) officially went into effect in May 2021, while the In-Vitro Device Regulation (IVDR) took effect in May 2022. The new legislatio [...]
AssurX Names Stephanie Ojeda as Director of Product Management for Life Sciences Industry
Morgan Hill, CA., June 22, 2022 — AssurX, Inc. (AssurX), a leader in quality management and regulatory compliance software, today announced the appointment of Stephanie Ojeda as Direct [...]
5 Ways an EQMS Resolves Change Management and Change Control Pains
In the life science industry, adjustments are a necessary element throughout the product lifecycle. From R&D through post-market, changes both big and small are inevitable in docum [...]
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 [...]
