Healthcare innovation at the speed of science

We build the intelligent compliance backbone for medtech software.
Find out how your business, and your future patients, can benefit from BeneDoc.

For Medtech Innovators

We speed up the path from concept to care—and help you sustain growth by cutting your regulatory overhead.

For Healthcare SaaS

We help healthcare SaaS build on the cutting edge while designing for HIPAA and SOC 2 from day one.

For Regulatory Teams

Automate away the tedium with our platform.

For Life Sciences Enterprise

We build customized software and provide the training and resources to maintain it.

SMARTER, FASTER COMPLIANCE

Accelerate your product’s journey from idea to patient

AI-Native Regulatory Intelligence Platform Features

We solve for fragmented workflows around regulatory operations. Build and integrate what you need today. Architect with foundations ready to adapt to change.

Submissions Builder

Navigating FDA regulations, device classification, QMS requirements, and postmarket reporting involves understanding hundreds of pages of guidance documents.

Regulatory Roadmap

Weigh progress, hazards, and burdens to figure out which regulatory pathway is the best strategy for your needs. Our engine identifies where your device fits in the current landscape, surfacing the most efficient path to clearance based on historical data, not guesswork.

Project Management Tracker

Collaborative tracking and customized project dashboards give you what you need to know at a glance, while our integrations allow you to automate away the pain of interdependent updates, formatting requirements, and reduplicated work.

Autonomous Policy Ingestion

Our system stays in sync with regulatory documents, identifying and ingesting published updates the moment they occur.

Total Ecosystem or Modular Fit

Use the full platform for end-to-end oversight or pull specific modules to solve targeted bottlenecks in your current pipeline.

PRODUCT DIFFERENTIATORS

Dedicated to open-source and compatibility

We believe regulatory infrastructure should be a public good. Our tools are built to be open, compatible, and transparent.

Targeted Solutions

Choose the specific components that meet their specific needs. Scale and adapt your workflow over time.

Seamless Integration

Built to integrate with existing tools (Jira, GitHub, QMS platforms) through standardized, machine-readable formats.

Regulatory Roadmap

Scale with Your Business

We focus on flexible tools that allow teams of all sizes to access the resources they need when they actually need them.

Context-Aware Intelligence

Automated document comprehension and regulatory strategy guidance, saving teams time and money.

Built for Real-World Workflows

Integrate what you need for your team — from traceable product design to post-market surveillance.

Total Ecosystem or Modular Fit

Our open-source core ensures you always have access to your regulatory data and logic, regardless of our platform.

CONSULTING & DEVELOPMENT SERVICES

Transform your innovation into compliant and scalable software.

We don't just build your idea — we make sure you stay agile and audit-ready. By applying the same architecture and product management rigor used to launch our own platform, we deliver secure and robust solutions that are engineered for sustained business impact.

End-to-End Software Development

From the first line of code to final audit, we engineer applications that meet the most rigorous security and risk management standards.

Compliance-by-Design

We provide the technical and regulatory blueprint needed to build in the highly governed spaces of life sciences. By integrating risk management directly into your product strategy, we help you avoid costly mid-cycle pivots and ensure your platform is "compliant-by-default."

Observable Systems

From tight version control to automated risk scanning and predictive risk modeling, our solutions are engineered with a traceability-first mindset aligned to FDA design traceability expectations, IEC 62304 configuration management, and SOC 2 Type II operational controls.

AI-Native

We don't just "add AI"—we engineer around regulated software expectations, to create innovative AI-enabled workflows.

Strategic Insight Meets Agile Engineering

We bridge the gap between rigorous regulatory requirements and the need for product velocity. Our approach combines data-backed strategic foresight with high-integrity engineering, ensuring that your software is not just compliant today, but remains flexible enough to evolve as the landscape shifts tomorrow.

Intelligence-Led Strategy

We don't guess at regulatory requirements. We analyze historical data and industry trends to understand how regulations impact business operations in the real world.

Adaptable, Audit-Ready Software

We use a "compliant-by-design" framework that allows rapid product changes without compromising the system's integrity or its audit trail.

Elastic, Expert-Led Talent Scaling

Innovation requires different skills at different stages. We scale your project team dynamically, blending our core full-stack developers with off-the-shelf software accelerators and a vetted network of subject-matter experts.

Expertise you can rely on

Integrate digital technologies into medical technology requires deep technical expertise. We build reliable, compliant, and high-performing software.

Data Pipelines

We have deep expertise in building data pipelines for model training, document understanding systems, and clinical voice agents.

Traceable Engineering

Every line of code is linked to a requirement and a risk analysis. We automate the generation of your Trace Matrix.

HIPAA-Compliant Infrastructure

We deploy secure, scalable infrastructure on AWS or Azure with SOC 2-ready access controls and encryption standards baked in.

Ready to build smarter?

We can help you move your health tech product forward.