Development Process
How we approach software development from planning through validation.
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.
LightBlueWhen (and When Not) to Use Virtual Devices in LightBlue
Should you test against a simulated peripheral or real hardware? This article breaks down when LightBlue Virtual Devices are useful and when relying on them can hide integration issues you need to catch.
Embedded SoftwareWhy Early Firmware Planning Matters More Than You Think
Poor planning in embedded firmware development can lead to costly delays, rework, and regulatory risk—especially in connected medical devices. This article breaks down four early decisions that have long-term impact: chip selection, manufacturing alignment, testing strategy, and security.
- Cloud & Backend
The Cloud Architecture Review Process for Regulated Connected Systems
Running an architecture review requires more than technical expertise. This article walks through the process teams use to surface risks, align decisions, and adapt over time.
- Embedded Software
Avoid Firmware Failures with a System-Level Approach to Connected Medical Devices
Firmware doesn’t operate in isolation, here we explore how a system-level approach helps prevent integration failures, from planning through delivery.
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