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AssurX BlogQuality, compliance and risk management straight talk for regulated industries.

Elements of a Modern Change Management System

Energy & Utilities Industry Medical Device Industry FDA Regulated Industries Pharmaceutical Industry Quality Management Regulatory Compliance Management

AssurX BlogQuality, compliance and risk management straight talk for regulated industries.

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Blog Home TAG: Change Management

Elements of a Modern Change Management System

By AssurX

In Energy & Utilities Industry, Medical Device Industry, FDA Regulated Industries, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management

Posted February 21, 2018

Elements of a Modern Change Management System

When a change management system is designed effectively, it defines how strategies, procedures and technologies will be applied to address changes in the business environment. Implementing a [...]

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

By Michael Causey

In Medical Device Industry, FDA Regulated Industries, Quality Management, Regulatory Compliance Management

Posted October 31, 2016

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

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 [...]

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