Description
The Cybersecurity Risk Management Plan template is your ultimate solution for ensuring regulatory compliance and robust cybersecurity for software-related medical devices. Designed to meet the rigorous standards of both FDA and EU MDCG cybersecurity guidelines, this document provides a clear, actionable framework to manage risks throughout the product lifecycle. Whether you’re preparing a premarket submission or managing postmarket obligations, this template will save you time, simplify compliance, and bolster your cybersecurity practices.
The cybersecurity risk management plan is part of our Cybersecurity Documentation toolkit, that can be used to ease compliance with cybersecurity requirements.
Why Choose Our Cybersecurity Risk Management Plan Template?
- Regulatory Compliance Made Easy
This template aligns seamlessly with:- The FDA’s “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (2023), which outlines requirements for risk management, threat mitigation, and security controls.
- The FDA’s “Postmarket Management of Cybersecurity in Medical Devices” (2016), emphasizing ongoing monitoring and vulnerability management after product deployment.
- EU MDCG guidance documents addressing cybersecurity requirements under the Medical Device Regulation (EU MDR) for lifecycle cybersecurity management.
With this document, you’ll meet the expectations of both U.S. and European regulators, reducing the risk of delays in approval and postmarket complications.
- Comprehensive Risk Management Framework
The plan includes everything you need to manage cybersecurity risks effectively:- Risk Identification: Guidance on recognizing vulnerabilities, threats, and potential impacts.
- Risk Assessment: Detailed methodologies for evaluating and prioritizing risks based on severity and exploitability.
- Mitigation Strategies: Practical approaches to minimize risks, including risk transfer, avoidance, and acceptance.
- Monitoring and Reporting: Clear instructions for tracking risks, documenting mitigations, and communicating findings to stakeholders.
- Customizable and User-Friendly
This template is designed for flexibility, enabling you to adapt it to your specific processes, device types, and operational needs. Pre-written content and editable fields streamline customization, ensuring you can tailor the plan without unnecessary effort.
Key Features of the Template
- Lifecycle-Centric Approach: Covers cybersecurity risk management across all phases of the device lifecycle, from design and development to postmarket surveillance.
- Integration with Regulatory Requirements: Includes prompts and examples to demonstrate compliance with FDA premarket and postmarket expectations and EU MDR cybersecurity mandates.
- Stakeholder Communication: Details processes for notifying regulatory authorities, healthcare providers, and patients about significant risks or vulnerabilities.
- Audit-Ready Format: Designed to facilitate audits and inspections by regulatory bodies or notified bodies.
