Software as a Medical Device (SAMD) R&D

Healthcare

Software as a Medical Device (SaMD) is where medicine, engineering, and regulation converge. Building AI-powered clinical software isn’t just a technical challenge—it’s a compliance and validation challenge. SaMD products must meet stringent FDA, CE, MDR, and ISO standards while maintaining reliability, reproducibility, and clinical safety under real-world conditions.

Theta Tech helps healthcare innovators turn research-grade AI into certified, deployable medical software. We design full-stack SaMD solutions that combine intelligent modeling, secure infrastructure, clinical usability, and regulatory readiness. Whether you’re a medical device company, digital health startup, or clinical innovation lab, we build systems that elevate your AI from prototype to regulated product.

Understanding the Concept

SaMD refers to standalone software that performs medical functions—diagnosis, prediction, analysis, triage, monitoring, and clinical decision support. Because these systems influence patient outcomes, the development lifecycle must be tightly controlled, traceable, and quantifiable.

This requires excellence across multiple layers:

Medical AI algorithms built with safety, interpretability, and dataset governance.
Backend architectures that ensure reliability, data protection, and low latency.
User-facing software designed for clinicians, researchers, or device operators.
Validation pipelines compliant with regulatory standards and clinical study requirements.

Theta Tech manages every part of this lifecycle—from early R&D to infrastructure, deployment, clinical usability, and system hardening.

Why This Matters

Develop, validate, and deploy AI-driven medical software that meets regulatory standards and clinical needs.

Bringing an AI medical product to market without a SaMD-ready workflow is a recipe for delays, rejection, or regulatory failure. Many AI teams can build a model; very few can package it into a compliant medical product that withstands scrutiny from auditors, regulatory bodies, or clinical partners.

Theta Tech bridges this gap with deep experience in medical AI engineering and SaMD development. We integrate compliance into the architecture from day one, ensuring your system is traceable, testable, auditable, secure, and ready for real-world use. With the right engineering and regulatory mindset, AI becomes a clinical asset—not a compliance risk.

Full-stack SaMD development for AI-driven medical applications, built with compliance and scalability in mind.

Sub-Services

AI-Powered Clinical Software:
Regulatory-compliant AI applications for diagnostics, triage, treatment planning, and clinical decision support.

Cloud & On-Premise Deployment:
Secure infrastructures for clinical environments, using containerized and serverless architectures tailored for compliance.

Machine Learning Model Integration:
Embedding validated AI models directly into clinical workflows with explainability and safety controls.

End-to-End Software Development:
From early prototypes to production-ready SaMD applications engineered for reliability, audits, and scalability.

Automated Reporting & Decision Support:
AI-driven insights that reduce clinician workload and improve decision-making accuracy—built with transparency and accountability.

The Result

A fully engineered, regulation-ready SaMD solution that transforms AI research into clinical reality.

Reliable, scalable, compliant, and built with the rigor required for medical deployment—

Theta Tech turns your innovation into a certified medical device.

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General AI Services

Agents

Theta Tech designs agentic systems: AI entities capable of independent reasoning, tool use, and adaptive decision-making.

Evaluation

Theta Tech constructs continuous evaluation frameworks that measure the true performance of AI systems.

Infrastructure

We build secure, scalable, and private AI environments for organizations where data integrity and latency are non-negotiable.

Model Training

We craft models that align with your objectives: LLMs, computer vision systems, or time-series predictors alike.

Product Development

We build AI that fits seamlessly into your product’s workflow and delivers tangible outcomes.

RAG

We engineer Retrieval-Augmented Generation systems that fuse reasoning with real knowledge.

Strategy

We help organizations think beyond deployment—designing ecosystems where intelligence compounds value over time.

Enterprise Services

AI Governance & Ethics Frameworks

Establish organization-wide governance for ethical, transparent, and auditable AI operations.

Custom Model Training & Optimization

Fine-tune and optimize foundation models to understand your language, tone, and workflows.

Digital Twin Systems

Simulate and optimize operations through real-time, AI-driven digital twins.

Enterprise AI Strategy & Governance

Architect end-to-end AI strategies that translate innovation into measurable, governed impact across the entire organization.

Enterprise Knowledge Architecture

Integrate all your organizational data into a unified, queryable AI knowledge layer.

Model Lifecycle & Evaluation Systems

Establish continuous AI evaluation pipelines to monitor accuracy, drift, and compliance at scale.

Multi-Agent Ecosystems

Deploy structured networks of autonomous AI agents for complex reasoning and operations.

Private AI Infrastructure

Build sovereign, scalable, and secure AI infrastructure tailored to enterprise workloads.

Small & Midsize Business Services

AI Infrastructure & Hosting

Host secure, high-performance AI environments designed for your scale and compliance needs.

AI Product Enhancement

Add intelligent features to your existing products without rebuilding from scratch.

AI Readiness & Strategy Assessment

Define your roadmap for adopting, scaling, and governing AI effectively.

Evaluation & Quality Monitoring

Ensure your AI stays accurate, aligned, and auditable with continuous evaluation systems.

RAG Knowledge Systems

Give your business a private AI that understands your documents, policies, and workflows.

Workflow Automation & AI Agents

Automate repetitive processes and scale operations with Theta Tech’s intelligent agent systems.

Startup Services

AI Product Acceleration

Turn your AI ideas into investor-ready products faster with Theta Tech’s end-to-end development.

Custom Model Training

Fine-tune open-weight models to learn your niche, your tone, and your data.

Early Infrastructure Setup

Launch with scalable, secure AI infrastructure that won’t collapse when you grow.

Fractional AI Team

Access a full AI team without full-time hires — Theta Tech engineers become your in-house experts.

Funding & Proof of Concept Strategy

Use working AI prototypes to attract grants, investors, and early adopters.

Startup AI Audit

Discover the fastest path to traction with a focused audit of your AI stack, data, and opportunities.

Healthcare Services

Full-Stack Medical AI Development

From building webapps and notebooks, to cloud GPU training and boosted decision tree algorithm development, we do it all.

Medical Imaging Services

Using advanced AI and deep learning techniques, we develop cutting-edge solutions for medical image analysis, segmentation, and classification.

Healthcare Algorithm Design

We work with structured and unstructured medical data, integrating state-of-the-art techniques in deep learning, machine learning, and digital health analytics.

Medical Deep Learning Services

We design and deploy state-of-the-art neural networks tailored for medical applications.

Healthcare

Software as a Medical Device (SAMD) R&D

We design, develop, and scale AI-powered medical software that meets FDA, CE, and MDR regulatory requirements.

Healthcare

Case Studies

Real-World Impact

Explore our successful AI case studies.

Algorithm for Collaboration & Distribution

Updating disparate and unorganized AI algorithm code into cohesive and easily sharable notebooks.

Clinical UI Design for Radiology AI

Creating intuitive software interfaces that empower doctors and accelerate AI innovation

Developing 3D Radiology AI Solutions

Moving University Client to the Cloud with Open Source Medical AI Models

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Publications

Explore Our Work

See our 35+ Peer-Reviewed Publications & Patents.

Improved Active Shape Models for Segmentation of the Prostate on MR Imagery

Toth, R. “Improved Active Shape Models for Segmentation of the Prostate on MR Imagery,” M.S. Thesis, Rutgers University, 2010.

Evaluation of prostate segmentation algorithms for MRI: The PROMISE12 challenge

Litjens, G., Toth, R., van de Ven, W., Hoeks, C., Kerkstra, S., van Ginneken, B., Vincent, G., Guillard, G., Birbeck, N., Zhang, J., Strand, R., Malmberg, F., Ou, Y., Davatzikos, C., Kirschner, M., Jung, F., Yuan, J., Qiu, W., Gao, Q., Edwards, P.E., Maan, B., van der Heijden, F., Ghose, S., Mitra, J., Dowling, J., Barratt, D., Huisman, H., Madabhushi, A. “Evaluation of prostate segmentation algorithms for MRI: The PROMISE12 challenge.” Medical Image Analysis 25:18(2), Dec 2013 pp. 359-373. doi: 10.1016/j.media.2013.12.002

HistostitcherTM: An informatics software platform for reconstructing whole-mount prostate histology using the extensible imaging platform framework

Toth, R.J., Shih, N., Tomaszewski, J.E., Feldman, M.D., Kutter, O., Yu, D.N., Paulus, J.C., Paladini, G., Madabhushi, A., “HistostitcherTM: An informatics software platform for reconstructing whole-mount prostate histology using the extensible imaging platform framework.” Journal of Pathology Informatics 5(8), Mar 2014. doi: 10.4103/2153-3539.129441

A Domain Constrained Deformable (DoCD) Model for Co-registration of Pre- and Post-Radiated Prostate MRI

Toth, R., Traughber, B., Ellis, R., Kurhanewicz, J., Madabhushi, A., “A Domain Constrained Deformable (DoCD) Model for Co-registration of Pre- and Post-Radiated Prostate MRI.” Neurocomputing 144(20) Nov 2014. pp. 3-12 doi: 10.1016/j.neucom.2014.01.058

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"Theta Tech AI is an exciting medical AI consulting company whom we’ve worked with for over a decade.

Their team of experienced healthcare AI developers and PhD level biomedical engineers have helped us accelerate our clinical AI research implementation efforts.
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Their team is hardworking and extremely responsive.
If you’re in the healthcare technology space, you’d be remiss to not work with Theta Tech."

Professor Anant Madabhushi

Executive Director for the Emory Empathetic AI for Health Institute

"Theta Tech AI brings together biomedical engineers and medical imaging experts who deeply understand both AI and clinical practice.

For anyone working in healthcare AI—especially at a leading university or tech company—they are a fantastic team to collaborate with."

Assistant Professor Andrew Janowczyk

Emory University

"Theta Tech AI is an outstanding team of biomedical engineers and medical imaging software experts, who can provide you with specialized healthcare AI solutions that will ensure successful ventures in this space."

Satish E. Viswanath, PhD

Associate Professor, Department of Biomedical Engineering

"Theta Tech AI is a highly competent healthcare AI consulting company that has deep expertise spanning machine learning, data science, medical data, image analysis, comprising of a great team of biomedical engineers."

Mike Galvin

Co-Founder & Chairman of LivAI

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