Regulatory Compliance
Meeting the technical requirements for FDA approvals of regulated connected medical devices.
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.
- Cloud & Backend
Choosing the Right EMR Integration Strategy for Connected Medical Devices
Identify when gateway, API, or FHIR‑bridge patterns best connect medical devices to EMRs, reducing integration risk, controlling costs, and scaling secure data exchange.
Connected Medical DevicesCryptographic 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.
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