Accelerating compliant innovation with AI-in-the-loop engineering
Overview
In an era of stringent regulation, accelerated innovation cycles and uncompromising demands for precision and safety, OEMs in the healthcare sector must uphold the highest standards of quality, traceability and compliance - particularly under frameworks like the EU Medical Device Regulation (EU-MDR).
Our client, a leading Germany-based OEM of diagnostic and therapeutic medical devices, has been at the forefront of medical innovation for decades and has trusted HCLTech for over ten years as a strategic engineering and digital transformation partner. To accelerate product development while ensuring full regulatory compliance, they selected us as their engineering partner to modernize their Siemens Polarion Application Lifecycle Management (ALM) environment with GenAI automation.
We evaluated requirement quality in line with International Council on Systems Engineering (INCOSE) best practices, generated requirement and test case drafts and translated and summarized documentation while maintaining end-to-end traceability. These capabilities empowered the client to innovate faster and with confidence, meeting the most stringent global standards.
The challenge
In the highly regulated healthcare sector, authoring clear, testable software requirements and maintaining end-to-end traceability are essential for ensuring safety, compliance and timely product delivery. The client had established comprehensive requirements engineering and traceability workflows; however, these processes involved significant manual effort and relied on specialized expertise. Activities such as validating requirement quality against INCOSE guidelines, generating verification test cases and summarizing extensive documentation for globally distributed teams required considerable time and resources.
While these methods supported regulatory demands, there was an opportunity to enhance scalability, accelerate review and design-control cycles and strengthen compliance assurance in a safety-critical environment. Implementing consistent, efficient quality checks and streamlining documentation review could further improve responsiveness and support faster product releases without compromising traceability and auditability.
To unlock these improvements, the client partnered with our team to explore how GenAI could augment their existing Polarion ALM ecosystem. The objective was to enhance requirement validation, automate test case generation and distill large document sets into concise, actionable insights while maintaining full traceability, auditability and regulatory compliance.
The solution
The solution enabled modernization of requirements engineering and testing within the client’s Polarion ALM environment. Designed for a regulated healthcare setting, the solution enhances speed, quality and compliance without sacrificing control — empowering teams to accelerate product development, improve requirement accuracy and maintain full traceability in line with stringent global standards.
Key highlights
- Automated content creation and summarization: Used GenAI to draft requirement text from inputs, produce concise summaries for rapid onboarding.
- Quality evaluation aligned to INCOSE and custom rules: Codified checks for well-formed requirements (e.g., clarity, verifiability), returning quality scores and actionable improvements directly in the workflow.
- AI‑assisted test generation: Generated candidate test cases from requirements to accelerate downstream verification and provide reviewers with a stronger starting point for refinement.
- Traceability‑first design: All generated artefacts preserve links back to sources, maintaining traceability throughout the lifecycle and supporting audits in the client’s ecosystem.
- Compliance guardrails for medical standards: Established a validation process to check requirements against applicable medical standards, providing reviewers with targeted alerts and guidance.
The impact
We transformed the client’s requirements engineering and testing processes, delivering immediate productivity gains while reinforcing regulatory compliance. By embedding AI into a human-in-the-loop framework, the solution has accelerated content creation, improved requirement quality and streamlined verification, without compromising traceability or control. This approach facilitated the client to meet demanding healthcare standards while innovating at greater speed.
Accelerated content delivery
- 30% reduction achieved in time and effort for authoring, summarizing requirements
- Enabled faster onboarding and knowledge transfer for global engineering teams
Higher-quality requirements
- 50% improvement delivered in requirement quality against INCOSE
- Reduced ambiguity, inconsistency and errors at the source, minimizing costly downstream rework
Faster review and release readiness
- Shortened review cycles by 45%, accelerating release timelines
- Provided reviewers with AI-generated drafts and targeted improvements for quicker decision-making
Future-ready expansion
- Scaling the GenAI toolkit to additional product lines and deepening Polarion integration
- Enhancing reuse libraries, coverage analytics and AI-assisted test design capabilities
