Services

Our Services

Cybersecurity Expertise For Organizations Who Develop Medical Devices and Healthcare Technology

Below are the core services Apraciti provides; however, we're here to help you with any Product Security needs.

Product Security Engineering Support

Provide ongoing product security & engineering support, including design discussions and reviews, analysis of security testing results, answering questions from regulatory agencies, completing questionnaires from healthcare delivery organizations and more.

Regulatory Submission & Go to Market Support

Lead and perform key cybersecurity activities, including architecture/data flow diagram development, threat modeling, requirements documentation, support with security testing, support with V&V testing, labeling (IFU, MDS2 form) and submission guidance.

Cybersecurity & QMS Integration

Develop processes, work instructions and templates for product security SOP aligned to regulatory guidance - total product lifecycle approach and fully integrate with a quality management system.