As technology continually changes, keeping medical devices secure is much more important than ever. It’s not just about the best software on your device, but you also need to follow the right regulations and have detailed documentation demonstrating the cybersecurity measures that you have implemented. Given the importance of cybersecurity, let’s go over the essential cybersecurity documents and a compliance checklist that you must follow.
Let’s dive in…
Key Cybersecurity Documentation for Medical Devices
1. The Security Risk Management Report (SRMR)
This is your go-to document for identifying and managing cybersecurity risks. It helps ensure your device stays safe and that you meet regulatory requirements.
What it includes
● Risks from the software, hardware, and networks
● Methods like the Failure Mode and Effects Analysis (FMEA) to assess risks
● Ways to minimize these risks, like encryption and access controls
Why it matters: This report shows you’re actively managing risks, which not only keeps your device secure but also builds trust amongst users and regulators.
2. Software Bill of Materials (SBOM)
This list details all the software used in your device—whether it’s your own code or open-source. If any vulnerabilities pop up, it helps you act fast.
What it includes
● A list of software applications and where they come from
● The Software versions and licenses
● What are known vulnerabilities and links to databases like common vulnerabilities and exposure (CVE)
Why it’s important: The FDA and other regulators want to see this transparency, and it helps you stay ahead of potential security issues.
3. Vulnerability Disclosure Policy (VDP)
The Vulnerability disclosure policy allows users to report any cybersecurity problems they find. It makes sure you’re open to feedback and working to improve security.
What it includes
● Clear instructions for reporting issues
● Timelines for fixing those problems
● Contact details for submitting reports
Why it matters: A good VDP shows you’re serious about fixing security problems and working with others to keep your device safe.
4. Incident Response Plan (IRP)
This plan outlines what you’ll do if there’s a cybersecurity incident. It is crucial to keep your device back up and running quickly.
What it includes
● How to detect security breaches
● How to deal and neutralize threats
● Includes recovery steps to get back to normal
Why it matters: Having a plan in place will help you respond quickly, reduce downtime, and stay compliant.
5. Cybersecurity Maintenance and Update Policy
This document explains how to handle software updates and security patches throughout the device’s life.
What it includes
● A schedule for regular updates
● Testing to ensure updates don’t create new issues
● A way to notify users about important updates
Why it matters: Always keep your device updated, which will help you stay ahead of new threats and meet regulatory expectations.
6. Access Control Policy
This policy makes sure only authorized people can access your device and its data.
What it includes
● Secure logins, like multi-factor authentication
● Access levels based on job roles
● Audit logs to track who’s accessing what
Why it matters: Limiting access reduces the risk of unauthorized changes and keeps your device more secure.
Why is this documentation important?
- Compliance
Having the right documents in place helps you meet global regulations like FDA, EU MDR, and ISO standards. - Establish Trust
When users and regulators see that you’re following these practices, they’ll trust that your device is secure. - Resilience
Proactively managing risks helps keep your device safe from cyber threats while still operating smoothly.
If you are pursuing a new submission, cybersecurity is an essential requirement to adhere to. Download the typical cybersecurity questions that the regulatory bodies ask during their review.
If you are a company that already has a medical device in the market, think about upgrading your cybersecurity measures to improve your device’s safety.
Medical device companies have received warning letters and had to undertake recalls due to their inability to meet the cybersecurity requirements. This cost the medical device companies a lot of effort, time, and money. A proactive approach is to design your quality systems in such a way that cybersecurity requirements are embedded in your design review and at every applicable phase of the medical device lifecycle.
Here’s an announcement made by the FDA where they alerted laboratories and healthcare providers to a cybersecurity vulnerability affecting the software used in several Illumina next-generation sequencing instruments. These devices are classified as medical devices and are used either for clinical diagnostics, such as DNA sequencing or genetic testing or for research purposes only (RUO).
Here’s a recall that Illumina, Inc. took up their medical device.
Why Documentation and Compliance Matter for Medical Devices
Setting Trust
Clear, transparent documentation lets everyone know your device is safe.
Risk Mitigation
Staying ahead of potential issues helps protect your device from emerging threats.
Simplification of Compliance
Having everything organized makes it easier to follow the rules. When you follow these steps, you make your device more secure and show healthcare providers and patients that you take security seriously.
Speedy approvals
Providing the right documents during the submission process is essential to get speedy approval. The inability to follow the documentation requirements can result in a lot of back and forth and delays in review.
