Quality Management Review

25 08, 2022

EU MDR & IVDR Regulation: Where Does the Guidance Stand?

By |2023-03-09T00:38:13+00:00August 25th, 2022|EU MDR, FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

Companies marketing devices in the European Union are facing a perfect storm of [...]

26 07, 2022

How to Establish Sustainable Validation for FDA & EU Compliance

By |2023-09-07T22:44:48+00:00July 26th, 2022|Document Management, FDA Regulated Industries, Manufacturing Industries, Quality Management, Regulatory Compliance Management, Sustainable Validation|

Software validation is historically one of the most difficult compliance activit [...]

13 07, 2022

QMS Configuration vs. Out-of-the-Box: Real-World Considerations

By |2024-01-13T02:05:02+00:00July 13th, 2022|Document Management, FDA Regulated Industries, Manufacturing Industries, Quality Management, Regulatory Compliance Management, Risk Management|

When evaluating an automated QMS, the question to invest in configuration vs. ou [...]

26 05, 2022

EU Medical Device Regulation Still Presents Challenges and Opportunities

By |2024-01-13T02:45:31+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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