Regulatory Compliance
Meeting the technical requirements for FDA approvals of regulated connected medical devices.
Connected Medical DevicesConnected 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…
Connected Medical DevicesIs 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.
Connected Medical DevicesBuilding 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…
- Connected Medical Devices
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.
Embedded SoftwareBuilding a Risk-Aligned Testing Strategy for Your Embedded Medical Device
Build a compliant embedded testing strategy that aligns with real-world risk, supports IEC 62304 and ISO 14971, and helps your connected medical device meet regulatory and safety expectations.
- Development & Delivery
Delivering Regulatory-Ready Software for Connected Medical Devices
Discover how we deliver regulatory-ready software for connected medical devices by embedding compliance into system architecture, risk management, and validation to accelerate submission readiness and reducing development risk.
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