Connected Medical Devices
Guidance and insights on developing compliant, secure software for Bluetooth- and cloud-connected medical devices.
Delivering Regulatory-Ready Software for Connected Medical Devices
April 18, 2025 • Punch Through
Connected Medical Device Cybersecurity: Why Deliverables Aren’t Enough
Most teams don’t fail FDA cybersecurity review because they lack technical skill. They fail because security was treated as a deliverable instead of a system. Under QMSR, that distinction is no longer subtle and fixing it late is far more…
Is Your Connected Device Architecture Ready for Continuous Oversight?
FDA’s expanding TAP Program signals a shift toward continuous oversight for connected medical devices. That shift changes what teams need to design for: not just functionality, but architecture that can prove performance, traceability, and control across the product lifecycle.
Building Secure, FDA-Compliant Medical Devices with the SPDF Framework
If you’re a medical device engineer, you’ve likely noticed the ground shifting beneath your feet. With the FDA's latest cybersecurity guidance released in 2025, the expectations for device security have become more stringent than ever, especially for what the agency…
FDA Cybersecurity Rules Raise the Stakes for Medical Device Software Teams
FDA’s new cybersecurity rules raise the bar for how medical devices are designed, updated, and maintained. This article breaks down what’s changed, what software teams need to show, and how to avoid common compliance pitfalls.
Cryptographic Key Management: How To Secure Implantable Medical Devices
Learn how to design secure cryptographic key management for implantable medical devices, from key generation and storage to usage and rotation, focused on firmware-level decisions within the implant itself.
What to Consider Before Building a Mobile Medical App
Explore key considerations for building mobile medical apps that connect to medical devices. Learn how to navigate BLE, data handling, compliance, and real-world challenges in regulated environments.
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