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FDA QMSR Surprise: Cybersecurity Just Moved Into the QMS
The quick version for busy people: FDA now aligns with ISO 13485. One global quality system. Nice. Cybersecurity is now clearly part of the QMS. Engineering and quality are about to spend more time together. Threat modeling, vulnerability management, and updates now live inside documented quality processes. Not just engineering notes anymore. You may need to buy ISO 13485 to read it. Regulatory harmonization apparently includes a shopping step. So What Actually Changed? The F
Firmware Security Playbook for MedTech Manufacturers
Medical device manufacturers already operate under intense pressure to meet safety, quality, and regulatory requirements. Cybersecurity adds another layer of responsibility, especially when it comes to firmware updates. Hospitals rely almost entirely on manufacturers to keep devices secure, and doing this well requires clear guidance, predictable processes, and practical tools. This playbook is meant to help. It outlines why firmware security has become a manufacturer's responsibility.
10 Ways to Gain Hospital Trust Through Device Security
Why Device Security Must Be a Manufacturer Priority Today’s medical devices are tightly connected to hospital networks, clinical systems, cloud platforms, and remote support tools. This improves patient care, but it also opens the door to cyber threats. If your device has a vulnerability, hospitals expect you to take the lead. One unpatched or misconfigured device can cause: Workflow disruptions and clinical downtime, Delayed diagnoses or treatments, Exposed patient data.
Managing Cybersecurity as a CAPA Event: 5 Steps to Handle Risks Effectively
Cybersecurity incidents are increasingly recognised as quality and compliance events that can affect the entire organisation, rather than being limited to the IT department. Because a single vulnerability could disrupt operations, compromise product integrity, or lead to regulatory noncompliance, cybersecurity issues must be handled with the same rigor as other CAPA events.
Top 10 Holiday Cybersecurity Risks and How to Stay Safe
The holiday season brings an extra level of excitement, with some free time to enjoy and relax, so it's no wonder many consider it one of the busiest times of the year. It often brings increased online activity, from shopping and banking to coordinating travel and sharing with friends and family. Cybercriminals know this fact and use it to take advantage of the busy season.
After the Breach: Rebuilding Trust and Resilience in Medical Devices
A 10 Point Framework for Responding to a Breach Connected medical devices have transformed patient care, but with connectivity comes exposure. Cyberattacks on medical device manufacturers now pose not only data privacy risks but also patient safety and regulatory consequences. When a breach occurs, the damage extends far beyond compromised systems. It strikes at the heart of what matters most: trust.
Legacy Medical Devices: Tackling Cybersecurity Concerns
Under the FDA’s updated rules (Section 524B of the FD&C Act), any medical device that includes software, connects to a network.
Mobile handset manufacturers insert spyware
Huawei, Xiaomi and OnePlus cellphones are sending extremely detailed personal information, app usage, system info back to their servers.