Regulatory Compliance Management

The “Regulatory Compliance Management” category at AssurX is dedicated to helping organizations navigate the complex landscape of regulatory requirements. This section provides practical tools and expert insights to ensure adherence to industry standards and regulations. It covers a range of topics, including compliance strategy development, risk assessment, and the integration of compliance management systems. By exploring these resources, professionals can streamline their compliance processes and mitigate risks effectively. AssurX equips you with the knowledge and solutions needed to maintain compliance and drive operational excellence.

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 [...]

20 04, 2022

Understanding FDA Alignment of ISO 13485 with Quality System Regulation

By |2024-03-04T21:30:05+00:00April 20th, 2022|FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

The FDA’s official proposal to align its Quality System Regulation (QSR) with IS [...]

31 03, 2022

miraDry Implements AssurX Quality Management and Regulatory Compliance Software

By |2024-01-13T02:06:41+00:00March 31st, 2022|Complaint Management, FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

MORGAN HILL, CA, UNITED STATES, March 31, 2022 – AssurX, Inc. (AssurX), a leader [...]

31 03, 2022

How an EQMS can Reduce CAPA and Complaint Observation Trends

By |2025-05-07T23:13:18+00:00March 31st, 2022|FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

As we move through 2022, we look forward to new opportunities, new challenges, [...]

24 03, 2022

5 Tips for Turning GMP Audits from an Adversarial to a Cooperative Process

By |2022-03-24T07:27:10+00:00March 24th, 2022|FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

This article is part two of a two-part series focused on GMP quality audit manag [...]

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