apraciti

Cybersecurity & Quality Management
System Integration

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1-215-613-9900

info@apraciti.com

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.

Services

Product Security
Engineering Support

Regulatory Submission & Go to Market Support

Cybersecurity & QMS Integration

Premarket Product Security Processes

Post Market Product Security Processes

Post Market Product Security Processes

Product Security Impact Assessment

Architecture Design & Threat Modeling

External Communications

Routine Update And Patch Management

Coordinated Vulnerability Disclosure Website Language

Design Control & Risk Management

Design Control & Risk Management

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