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BrightInsight Gherkin Compliance DSL

Problem Space

Automate compliance evidence generation across unit, contract, and BDD test layers for regulated medical device software. Provide a unified test language that maps directly to ISO 13485 and IEC 62304 audit requirements, ensuring traceable artefacts from every test execution.

Architecture & Patterns

  • Unified Gherkin-based DSL for QA — traceable test artefacts across unit, contract (Pact), and BDD layers
  • Direct mapping of test evidence to ISO 13485 and IEC 62304 audit requirements
  • CI/CD pipelines with embedded DevSecOps gates using GitHub Actions, Terraform, and Ansible
  • Contract testing integration via Pact within the DSL framework

Tools & Stack

Gherkin, Pact, GitHub Actions, Terraform, Ansible

Business Outcomes

  • Direct mapping of test evidence to ISO 13485 and IEC 62304 regulatory requirements
  • Improved audit readiness with traceable artefacts across all test layers
  • Embedded DevSecOps gates in CI/CD pipelines ensured compliance at every deployment

Regulated / Domain Context

ISO 13485, IEC 62304

Reusable Narrative Snippets

Designed a unified Gherkin-based DSL for QA that produces traceable test artefacts across unit, contract (Pact), and BDD layers, directly mapped to ISO 13485 and IEC 62304 audit requirements.

Embedded DevSecOps gates in CI/CD pipelines using GitHub Actions, Terraform, and Ansible to ensure compliance at every deployment stage.

Source Notes

  • Derived from role responsibilities and achievements in config/madu_profile.json
  • Confidence: high