Engineering Modern GxP & SaMD Ecosystems

Efficiency + compliance, built into your development workflow.

We help Pharma and MedTech teams build and validate digital products using Regulatory‑as‑Code, automated testing, and AI‑assisted evidence generation. Stop treating compliance as a brake. Start using it as the engine to move fast and stay audit-ready.

We implemented GxP and SaMD solutions across R&D, Digital Health, Medical Devices, Clinical Data, Regulatory Submission, and Post‑Market Surveillance trusted by leaders.

How Micromove delivers High-Assurance Speed

1. Structure Requirements (The Prompt)

Traceability from Day 1. We define clear requirement models that connect design inputs to risks. These become the structured context that guides developers and AI agents.

2. Encode Compliance (The Guardrail)

Documentation as Code. We move compliance into version control. Your requirements and evidence live alongside your code—the single source of truth for humans and machines.

3. Automate V&V (The Gate)

Continuous Verification. We build test automation pipelines that act as instant quality gates, generating reporting that non‑technical QA can trust and approve instantly.

4. Operationalize Learning (The Loop)

Closed-Loop Feedback. We connect post-market surveillance and complaint data directly back into your requirement models for the next release cycle.

AI-Assisted Evidence Generation Interface

Regulated software teams are stuck between speed and safety.

Most companies treat coding and documentation as separate streams, creating a "paperwork debt" that stalls innovation.

Documentation lags

Specs and reports grow faster than the product itself.

The AI Risk Trap

Teams adopt AI coding assistants to move faster, but without structured guardrails, they generate unmaintainable, non-compliant code at record speed.

Drift & Disconnect

Requirements, code, and tests drift apart, creating hidden risks that manual QA can't catch.

Compliance should not be an obstacle. It should be your navigation system.

In the era of AI-assisted coding, unstructured requirements create chaos. We act as the bridge, transforming your compliance needs into the structured context necessary for modern development.

We treat requirements, design constraints, and tests not as dead documentation, but as active guardrails. These structured inputs serve as the "prompt guide" for your AI agents and developers, ensuring every line of code generated is aligned with regulatory needs from the start. Without these guardrails, AI simply helps you build technical debt faster.

The Micromove Standard:

  • AI-Ready Inputs: Structured requirements that guide generative agents.
  • Audit‑ready evidence generated continuously via CI/CD.
  • Faster change cycles with controlled risks.