Description
The Cybersecurity Management Plan template is a must-have resource for medical device manufacturers seeking to ensure compliance with FDA and EU cybersecurity requirements. Designed specifically for software-related medical devices, this template provides a comprehensive framework to manage cybersecurity risks, processes, and responsibilities throughout the product lifecycle. Whether for premarket submissions or postmarket compliance, this document is your pathway to regulatory approval and robust cybersecurity management.
The cybersecurity management plan is part of our Cybersecurity Documentation toolkit, that can be used to ease compliance with cybersecurity requirements.
Why Choose Our Cybersecurity Management Plan Template?
- Regulatory Alignment
This template meets the stringent requirements outlined in:- The FDA’s “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (2023), focusing on integrating cybersecurity into quality systems.
- The FDA’s “Postmarket Management of Cybersecurity in Medical Devices” (2016), which emphasizes continuous monitoring, vulnerability mitigation, and coordinated disclosure.
- EU MDCG cybersecurity guidance under the Medical Device Regulation (EU MDR), ensuring compliance with European expectations for secure device management.
With this plan, you’ll confidently meet the expectations of regulatory bodies across multiple jurisdictions, reducing compliance risks and enhancing trust.
- Comprehensive Cybersecurity Framework
The plan addresses all critical components of cybersecurity management, including:- Roles and Responsibilities: Clear assignments of accountability for managing cybersecurity within your organization.
- Processes for Threat Identification and Mitigation: Practical strategies for identifying, assessing, and addressing vulnerabilities.
- Risk Communication: Guidance for notifying stakeholders, including regulators and healthcare providers, of cybersecurity risks and incidents.
- Postmarket Surveillance: Detailed instructions for monitoring and responding to emerging threats in deployed devices.
- Ease of Customization
This template is fully editable and includes prewritten content, sample text, and placeholders that can be tailored to your specific device and organizational requirements. It’s designed to save you time and ensure your plan is both comprehensive and personalized.
Key Features of the Template
- Lifecycle Integration: Covers cybersecurity practices from device development through deployment, use, and decommissioning.
- Incident Response and Escalation: Outlines protocols for handling cybersecurity incidents, including reporting to regulatory authorities and stakeholders.
- Alignment with Industry Standards: Reflects the principles of ISO 14971, ISO 27001, and other recognized frameworks to support risk-based decision-making.
- Audit-Ready Documentation: Ensures your organization is prepared for audits by regulators or notified bodies.
