Designing Secure Medical Devices: Building Cybersecurity into the Development Process
Are your medical devices hackable? If they’re connected to networks, other devices or the internet, you need Designing Secure Medical Devices: Building Cybersecurity into the Development Process.
You see, hackers are targeting your medical devices right now. And regulators are looking to you to step up, strengthen security and stay ahead of the threats.
Designing Secure Medical Devices explains how to incorporate risk and vulnerability assessment into each stage of development, from initial design to validation, testing and implementation, so you stay compliant and address the FDA’s requirements on cybersecurity and the policies of regulators in other regions.
This report shares how cybersecurity considerations can be built into your quality systems, presents common failures devicemakers have made — and the FDA has caught — and discusses how to demonstrate your device’s security in regulatory submissions and inspections, including building in security measures, firewalls and fail-safe functions to protect users from falling victim to hackers.
The U.S. Department of Health and Human Services listed medical devices as one of the top five cybersecurity threats: the smallest tampering or most innocent error can cost lives.
But when 70% of devices are estimated to be running outdated, no-longer-supported Windows operating systems — which may have critical vulnerabilities for which a patch was long-ago available — you have your work cut out for you.
Designing Secure Medical Devices is your cybersecurity insurance.
Management report takeaways:
- How cybersecurity relates to design controls specifically and the quality system more generally
- Key tips for explaining and defending cybersecurity measures during an FDA or other regulatory inspection
- How to educate investigators and auditors unfamiliar with cybersecurity issues
- How addressing cybersecurity risk relates to product risk management
- Common cybersecurity issues identified during inspections and submission reviews
- How to incorporate cybersecurity documentation into a device’s design history file
You can’t afford to ignore this threat. Stay compliant, protect your devices — and protect patients — with Designing Secure Medical Devices: Building Cybersecurity into the Development Process.
About the Contributor
Eric Henry is a senior quality systems and compliance adviser in the FDA and Life Sciences practice of the law firm King & Spalding. He has 30 years of global leadership and practitioner experience in a variety of quality, compliance and product development roles, with a specialization in large organizational change and remediation programs, software quality (including cybersecurity), medical device design controls, risk management, audit management and management controls.
Who Will Benefit
- Software engineers
- Quality assurance/engineering personnel
- Regulatory affairs personnel
- Legal professionals
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