Regulatory Strategy Project

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Case Study

Regulatory Strategy Project

QualityHub worked with one major medical device company before, during, and after a Consent Decree. Working with their in-house and external attorneys, we helped develop strategies to address FDA’s concerns, stabilize their quality system, and develop the necessary improvements to the organization and the quality system.  During this project, we also were able to provide Interim Professionals to assist with several positions in the company.

The work involved planning for and attending meetings with FDA, assisting in the formal written responses to FDA, and creating the overall plan/strategy that FDA was expecting to see.  Execution of the plan followed on this project – which lasted close to two years. We worked closely with the company’s senior management, in-house, and external attorneys throughout the project. For this project, QualityHub was not the certification auditor, but rather the organization helping the company rebuild and reshape their quality system.