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.
Modernization strategy
Decide where to invest, what to prioritize, what should happen first, and what evidence should change the plan.
Explore service ↗02Data engineering
Make data quality, ownership, lineage, and availability explicit before decisions or operating systems depend on them.
Explore service ↗03AI engineering
Use AI where it earns its place, from commodity capabilities and orchestration to proprietary engineering where organization-specific value justifies it.
Explore service ↗Put this sector view to work
Find out where you stand and what you can do about it.