Medical-device case study
West Pharma
The BLE communication layer for a medical device: a client-specified API and the protocol layers beneath it, in C, built to FDA-grade quality and documented for submission.
- BLE communication layer in C
- Client-defined API + protocol layers
- FDA-grade, documented for submission
The engagement
West Pharma was developing a medical device that, by agreement, we will not describe here. Our scope was focused and critical: the communication layer over BLE inside the device. We built the protocol layers and implemented a client-defined API, so the application could talk to the device cleanly and reliably.
What we built
A focused embedded engagement: the BLE communication layers, the API on top, and the quality and documentation a regulated device demands.
BLE communication layer
- The BLE communication inside the device, built layer by layer from the transport up to the application interface.
- A client-defined API: they specified the interface, we implemented every layer beneath it to their requirements, so the application could use BLE conveniently.
Quality, in C
- Embedded software written in C across the communication layer.
- Static analysis with Parasoft C/C++test, run to meet the standards an FDA submission requires.
Verification & documentation
- Tests written to verify that every requirement was met.
- Submission-ready documentation for regulatory bodies: SRS, SDD, test documents and traceability.
Technologies & tools
CBLECommunication layersClient-defined APIEmbedded softwareParasoft C/C++testStatic analysisRequirements verificationSRS / SDDTraceability & test docs
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