Regulatory Submission & Go to Market Support

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1-215-613-9900

info@apraciti.com

About Our Country
APRACITI is a world-class medical cybersecurity consulting and services company that helps medical device manufacturers and developers navigate the complex world of medical device cybersecurity. Our industry experts help company meet the regulatory and go-to-market challenges by delivering critical thinking and expertise.

Service Overview

Our team is capable of leading and performing key cybersecurity activities, including architecture/data flow diagram development, threat modeling, requirements documentation, guidance on security testing, support with verification and validation testing, labeling (IFU, MDS2 development) and submission guidance

Experienced Solutions

Architecture and Design Review Feedback
Support design sessions and review the overall product architecture from a Cybersecurity perspective, including hardware and software design, networking components, interfaces and any accessories to the product. This may involve attending a weeklong or multiple design review sessions.
Threat Modeling
Execute a threat model using an industry standard methodology, such as Microsoft STRIDE. This involves identifying all the assets requiring protection in the design (e.g. essential performance, health information, intellectual property, etc.), reviewing potential threats, and identifying controls and mitigations.
Product Security Risk Assesment
Identify, document, assess and discuss treatment planning for all gaps in the device from activities such as threat modeling, requirements implementation and security testing. The assessment may be performed using an industry approved or custom developed methodology in alignment with the organization’s needs (e.g. CVSS, CVSS healthcare rubric, custom risk assessment).
Design Input & Security Requirements
Develop high level design input and detailed system and software level security requirements for a product. The requirements are developed and traced to regulatory guidance (e.g. US FDA, HealthCanada, IMDRF, etc), industry standards (e.g. UL2900, NIST CSF) and publicly available information from healthcare delivery organizations.
Cybersecurity Testing & Verification and Validation Support
Support the product development and quality teams in the development and execution of testing of the implemented Cybersecurity controls, to provide full traceability.
Labeling
Provide guidance and draft language for inclusion in a products Instructions for Use (IFU) and a completed Manufacturers Disclosure Statement on Medical Device Security (MDS2) for the product, utilizing the latest available version of the MDS2 tool.