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
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.
How to Use Agile Frameworks in the Medical Device Industry
Despite regulatory hesitation, agile frameworks like Scrum improve software quality, predictability, and collaboration in medical device development when applied with care, structure, and the right support.
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