Skip to main content
FDA AI/ML 2021SaMD Class IIIEC 62304ISO 14971PCCP

Engineering Solutions, Accelerated by Intelligence

We engineer AI workflows for medical device and healthcare teams — Human-in-the-Loop solutions that respect Quality Management Systems and regulatory compliance, so innovation never comes at the cost of safety or accuracy.

Book a Discovery CallView All Services

Engineering-First AI

AI That Works Inside Your Compliance Framework

Most AI vendors bolt on safety after the fact. We build it into the workflow architecture from the start — every automation decision is traced, auditable, and QMS-compatible.

Workflow AI

AI-Driven Workflow Optimization

At MTS, we don't just implement AI — we engineer AI workflows. We focus on Human-in-the-Loop solutions that respect rigorous Quality Management Systems and regulatory compliance, ensuring that innovation never comes at the cost of safety or accuracy.

  • Automate repetitive technical tasks, from data synthesis to CAD-related communication
  • Human-in-the-Loop checkpoints that satisfy QMS audit requirements
  • Workflow designs that map to your existing IEC 62304 SDLC gates
Prompt Engineering

Strategic Prompt Engineering

Bespoke prompt libraries and training tailored for engineering teams to ensure accurate, technical LLM outputs — not generic responses, but domain-specific answers that hold up under regulatory scrutiny.

  • Custom prompt libraries built for medical device and regulatory language
  • Team training on effective, safe AI interaction patterns
  • Prompt versioning and audit trails for compliant LLM usage
Doc Automation

Regulatory & Documentation Automation

Reducing the overhead of technical reporting and regulatory filing through intelligent, structured content generation — without sacrificing the accuracy and traceability that FDA and notified body reviewers expect.

  • AI-assisted DHF section drafting with human review checkpoints
  • Structured generation of risk management documentation
  • Automated synthesis of V&V test summaries from raw data
Data Privacy

Your Data, Protected

We prioritize data privacy and auditability. Our strategies focus on enterprise-grade, secure AI implementations where your intellectual property and proprietary designs remain within your secure perimeter — never sent to external model providers without explicit controls.

  • On-premise or private-cloud AI deployment options
  • No proprietary design data leaving your secure environment
  • Full audit logs of AI-generated content for compliance traceability

Case Study — Engineering Productivity Reclaimed

From 10 Hours of Documentation to 1 Hour of Review

A medical device engineering team was spending 10+ hours per week writing and formatting technical reports. MTS deployed an AI-powered documentation workflow that transformed that burden into a 1-hour review task.

The MAAS Solution: Automated Prompt-Driven Workflow

Secure Data Synthesis

A custom AI agent was deployed to scan and summarize technical logs within a secure environment — no data leaving the client's infrastructure.

Strategic Prompt Engineering

Using bespoke prompt libraries, the AI was instructed to draft reports in a compliant, structured format matching the client's regulatory documentation standards.

Human-in-the-Loop Verification

The AI generated a high-fidelity draft, allowing engineers to simply review and validate the technical data rather than writing from scratch.

The Result: A 90% Efficiency Gain

10h → 1h

Time Reclaimed

Reporting time reduced from 10 hours to just 1 hour per cycle

9 hrs

Returned Weekly

Engineers refocused on design, testing, and strategic planning

90%

Efficiency Gain

Reduction in administrative friction accelerated time-to-market

"By integrating Generative AI expertise into the engineering lifecycle, the team transformed their weekly schedule — reclaiming 9 hours that were immediately redirected toward design, testing, and faster market entry."

— MTS AI Workflow Engagement

Ready to Get Started?

Looking to Build or Modernize Your Medical Device Software Platform?

Let's discuss how we can implement a compliant, scalable, and AI-enabled development strategy tailored to your device class and regulatory pathway.

Book a Discovery CallView All Services