RegulatoryChangeManagement

Regulatory Change Management

Manage the impact of changes in your medical devices

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The smart way to manage the impact of changes in your medical devices

The Essenvia RIM Platform allows you to easily manage change assessment and streamline collaboration between regulatory and other departments (e.g. QA,R&D).

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We work with regulatory businesses worldwide

How can the Essenvia RIM Platform help you manage the impact of changes on existing devices?

Change Assessment Automation

Native integration with PLM/ eQMS to automate change assessment.

Regulatory Intelligence

Regulatory intelligence to determine the impact of change (significant or insignificant change).

Faster Letter-to-file / Memo-to-file

Automate creation of letter to file/memo to file.

Project Management Made Easy

Project management across changes from initial assessment to closure.

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