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Life Sciences
FDA Expands Medical Device Cybersecurity Draft Guidance to Stress Importance of Quality System
As innovation in medical technology increases, potential cybersecurity threats also grow. The U.S. Food and Drug Adminis [...]
QMS Configuration vs. Out-of-the-Box: Real-World Considerations
When evaluating an automated QMS, the question to invest in configuration vs. out-of-the-box (OOTB) is a core functional [...]
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 Devi [...]
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 softwa [...]
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 [...]
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 [...]
