Description
The Threat Model Report Template is an essential document for medical device manufacturers seeking to identify, analyze, and mitigate cybersecurity threats to their software-related devices. Fully aligned with FDA and EU MDCG requirements, this template provides a structured approach to threat modeling, helping you strengthen device security, ensure regulatory compliance, and build trust with stakeholders.
The Threat Model Report Template is part of our Cybersecurity Documentation toolkit, that can be used to ease compliance with cybersecurity requirements.
Why Choose Our Threat Model Report Template?
- Regulatory Compliance Guaranteed
This template is designed to help you meet the requirements of:- FDA’s “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (2023), which mandates comprehensive threat modeling as part of the premarket process.
- FDA’s “Postmarket Management of Cybersecurity in Medical Devices” (2016), emphasizing continuous evaluation of threats and vulnerabilities.
- EU MDCG guidance under EU MDR, which highlights the importance of threat analysis and proactive risk management in medical devices.
By using this template, you ensure your threat modeling practices align with the latest regulatory expectations.
- Comprehensive Threat Analysis Framework
The template provides a step-by-step guide to conducting effective threat modeling, including:- Identifying Assets: Pinpointing critical data, system components, and processes that need protection.
- Defining Threats: Identifying potential threats, including unauthorized access, data breaches, and system manipulation.
- Assessing Vulnerabilities: Evaluating weaknesses that could be exploited by attackers.
- Risk Evaluation: Scoring threats based on their likelihood and potential impact on patient safety and device functionality.
- Mitigation Strategies: Developing targeted controls and safeguards to address identified threats and vulnerabilities.
- Customizable and Easy to Use
This template is fully editable, with prewritten sections and placeholders to guide you through the threat modeling process. Tailor it to your specific device and organizational needs without starting from scratch.
Key Features of the Template
- Lifecycle Focus: Incorporates threat modeling as an ongoing process throughout the device lifecycle, from design and development to postmarket monitoring.
- Integration with Risk Management: Aligns threat modeling outputs with your broader cybersecurity risk management framework, ensuring cohesive documentation.
- Incident Response Support: Identifies potential attack vectors to enhance incident response planning and preparedness.
- Regulatory Submission Ready: Structured to meet the expectations of regulatory bodies for premarket submissions and postmarket evaluations.
Who Should Use the Threat Model Report Template?
This template is perfect for:
- Medical device manufacturers preparing premarket submissions to FDA or EU MDR technical files.
- Startups seeking to implement robust threat modeling practices without extensive resources.
- Established companies looking to standardize their approach to threat analysis and reporting.
