Enterprise data engineering and compliant AI architecture for medical device companies.
We engineer the data and AI infrastructure for connected devices, SaMD, and quality management systems. Our solutions solve for scale while maintaining the compliance record.
Software defines the device.
Hardware differentiation is narrowing. Value has shifted to the software layer and the data it generates. Managing telemetry, over-the-air updates, and algorithmic improvements under FDA scrutiny requires architecture built specifically for auditability.
Validation over experimentation.
We build systems ready for 21 CFR Part 11 and ISO 13485 from the first commit. We decouple exploratory data science from regulated production paths to accelerate development without risking compliance.
Quality management and telemetry.
The immediate leverage exists in automating CAPA workflows, complaint handling, and post-market surveillance. We structure the incoming device telemetry so it supports both engineering iterations and regulatory reporting.
Three ways Talbot West works inside Medical Device.
Digital transformation strategy
Strategic advisory and architectural governance for enterprise modernization. Whatever the decision is, we quarterback it.
Explore service ↗02Data engineering
Settle data ownership, quality, and lineage before anything depends on it. We orchestrate the pipelines and master data infrastructure that makes reporting and AI trustworthy.
Explore service ↗03AI engineering
Harness engineering, AI and ML development, and systems integration under one roof. This is where the strategy becomes how you actually work.
Explore service ↗Put this sector view to work
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