Regulatory Compliance
Meeting the technical requirements for FDA approvals of regulated connected medical devices.
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 DevicesFDA 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.
- Cloud & Backend
How to Architect a Robust Medical Web API or App
Learn to build a secure and efficient medical web API and app with a high-level blueprint for development, maintenance, and operational excellence.
- Cloud & Backend
How To Evolve Cloud Architecture for Connected Medical Devices
Explore how connected medical device cloud architectures evolve over time, and learn strategies to support scalability, integration, and compliance across cloud, mobile, and embedded systems as product complexity increases.
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