GXP Systems

Design Control Remediation Project

Following an acquisition, our customer, a global provider of medical devices used for vascular access, surgery, respiratory and cardiac care relocated their in-house R&D department, which necessitated the transfer of all design history documents to one central location.

The aim of the project was to document design inputs & outputs for the Design History File (DHF) for a particular product range and to address any validation and verification deficiencies.

A team of Stericycle GxP Engineers worked closely with the customers own R&D team to ensure that the project was closed out well in advance of an FDA Audit.

In this case study, you will learn about the steps that we took in order to deliver a fully compliant design process on behalf of our customer.

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