Cybersecurity & Quality Management System Integration

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Service Overview

As medical device manufacturers mature their capabilities around building safe, secure, and trustworthy devices, they must also ensure there are consistent and repeatable processes in their quality management system. These processes should cover how cybersecurity is incorporated into the total-product-lifecycle from a products design through end of support/life.

With extensive experience working with quality management systems, APRACITI is uniquely qualified to develop and execute on an organization specific plan for full integrating cybersecurity. Through the development of new processes, work instructions and templates and the updating of existing ones, APRACITI will partner with your team to ensure cybersecurity is accounted for from design & development planning to complaint handling.

Premarket Product Security Processes
Product Security Risk Assessment
Architecture Design & Threat Modeling
Routine Update and Patch Management
Design Control & Risk Management
Post Market Product Security Processes
Product Security Impact Assessment
External Communications
Coordinated Vulnerability Disclosure Website Language
Post Market Surveillance, Complaint Handling and Change Control