Software as a Medical Device (SaMD) & FDA 21 CFR Part 11
Medical software that aids in diagnostic decision-making requires strict lifecycle governance. We build SaMD platforms following IEC 62304 software lifecycle processes, establishing end-to-end traceability matrices from clinical requirements to verification and validation.
Our systems fully comply with FDA 21 CFR Part 11 requirements for electronic records and signatures. We maintain comprehensive Design History Files (DHF) and automated test suites that give biomedical enterprises full confidence during FDA 510(k) submissions.
DICOM Imaging Pipelines, PACS & Cloud VNA Storage
High-resolution medical imaging demands specialized streaming and storage protocols. We develop cloud-native DICOM pipelines that interface with hospital PACS (Picture Archiving and Communication Systems) and Vendor Neutral Archives (VNA).
Using zero-footprint web viewers with WebGL acceleration, our platforms enable radiologists and specialists to render 3D volumetric CT/MRI scans in sub-second timeframes directly within modern web browsers with full lossless fidelity.
Clinical Decision Support & Laboratory Information Systems
Modern diagnostic labs require high-throughput automation to eliminate manual specimen tracking errors. We build custom Laboratory Information Management Systems (LIMS) that track chain of custody from specimen collection through instrument analysis.
We incorporate Clinical Decision Support (CDS) algorithms that analyze laboratory results and patient history against clinical guidelines, flagging critical contraindications and supporting medical teams with evidence-based diagnostic insights.
Deep Dive: Biomedical & Medical Device Engineering
Discover our specialized engineering capabilities for medical devices, diagnostic imaging, and regulated clinical laboratory systems.
HL7 FHIR v4 Integration & SMART-on-FHIR Clinical Interoperability
