Change Management

3 12, 2019

Elements of a Modern and Efficient Change Management System

By |2022-01-13T00:14:47+00:00December 3rd, 2019|Energy & Utilities Industry, FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management, Risk Management|

An efficiently designed change management system clearly defines how strategies, [...]

31 10, 2016

Is Your Change Control Program Ready for FDA 510(k) Scrutiny?

By |2023-03-08T22:42:36+00:00October 31st, 2016|Archives, FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

A trio of FDA 510(k) guidances demonstrate how important it is for medical device manufacturers to get a firm grip on document management and change control – especially when working within the Third Party (TP) Review Program or trying to determine if a medical device change warrants a new 510(k). The agency is attempting to make it easier on device makers if they understand how to work within the new system.

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