Success Stories

Learn how Greenleaf works with clients to devise effective solutions to their most complex regulatory challenges.

Medical Device Auditing and Certification for Compliance with FDA Guidelines

Greenleaf was selected by a multinational medical device company to serve as an independent GMP and Medical Device Reporting (MDR) expert. In this role, Greenleaf was made responsible for performing initial audits and procedural reviews at the company’s locations in the U.S. and Asia.

Greenleaf’s work started with a review of company policies and procedures; observation of company operations; evaluation of the company’s implementation of policies and procedures; and interviews with company officials. Upon completing the initial audit, Greenleaf developed an approved MDR work plan to address deviations identified by Greenleaf experts.

The Greenleaf team worked with the company to ensure sufficient corrective actions had been completed and performed MDR follow-up audits to confirm the findings were supported by objective evidence. These efforts resulted in a certification, deemed acceptable by the FDA, that the company’s policies and procedures were in compliance with FDA Medical Device Reporting guidelines.  

Greenleaf remains engaged with the company and has conducted additional audits to monitor and ensure operational compliance with the certified policies and procedures.