Medical Device Regulation

AssurX supports compliance with medical device regulations through comprehensive quality management solutions. Our platform ensures adherence to FDA standards, automating processes to enhance efficiency and data integrity. Experience seamless integration and real-time insights to maintain high compliance standards across your operations.

5 08, 2025

FDA Updates Cybersecurity Guidance for Medical Devices: 2025 Premarket Recommendations

By |2025-08-05T13:51:41+00:00August 5th, 2025|Document Management, eMDR, EU IVDR, EU MDR, Manufacturing Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

The U.S. Food and Drug Administration (FDA) released an updated guidance docume [...]

26 05, 2022

EU Medical Device Regulation Still Presents Challenges and Opportunities

By |2024-12-31T23:16:11+00:00May 26th, 2022|EU IVDR, EU MDR, FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management, Risk Management|

EU Medical Device Regulation (MDR) has been in effect for almost a year. As anti [...]

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