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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