Case Study Details

Case Study Information

Project Name: Post Market Product Security

Service: Cybersecurity & QMS Integration

Client: Private

Complete Date: 2019

Developed and helped implement a post market product security program for a multi-billion-dollar medical device company, enabling them to properly manage cybersecurity events on products in the market. 

This project was required to ensure cybersecurity was integrated in the organizations quality management system, in alignment with regulatory guidance, for post market management of products.  It helped ensure the organization had proper processes in place for dealing with cybersecurity vulnerabilities in their marketed products.

Device FDA Submission

The project involved the following:
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