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Siemens Polarion as Lifecycle ALM in the Medical Device Industry

Medical Devices

5/17/2026

Introduction

Medical device development is a demanding engineering discipline. It sits at the intersection of technology and stringent regulatory oversight, patient safety, and time-to-market pressure.

Every artefact in the technical documentation - from user requirements to a final validation report - must be documented, versioned, traceable, and auditable across the full product lifecycle.

Application Lifecycle Management (ALM) tools such as Siemens Polarion [1] have typically been used for requirements engineering or software testing. Its potential lies in serving as a full lifecycle ALM platform. In that setting, it would span design inputs and outputs, design transfer, together with post-market activities. However, the ideal world is not easy to pursue because of legacy island solutions, as I will also discuss.

Videos and tutorials on platforms like YouTube tend to focus on generic ALM use cases, leaving medical device professionals to discover through hands-on experience how deeply Polarion can be integrated into regulated product development.

This article explores how Polarion serves as a life cycle management tool, as I have experienced myself. I highlight Polarion's key structural advantages, and point to the growing ecosystem of specialized partners who tailor it for domain-specific needs.

What is Siemens Polarion ALM?

Siemens Polarion is a browser-based Application Lifecycle Management (ALM) platform that provides a unified environment for requirements management, test management, project planning, quality management, and regulatory compliance. It is part of the Siemens Xcelerator portfolio and is designed to model complex process relationships through a live-linked, relational database architecture [1].

It can run as an on-premise server (Polarion ALM), or as a Cloud solution (Polarion X).

At its core, Polarion treats every piece of information - whether a user need, a system requirement, a test case, a risk record, or a regulatory reference - as a Work Item: a discrete, uniquely identified, version-controlled artefact that can be linked to any other Work Item across the project or even across projects.

This paradigm fundamentally changes how lifecycle management is conducted, moving teams away from static Word documents and disconnected Excel spreadsheets toward a single source of truth.

Core Features: The Structural Advantages of Polarion

Work Items - The Single Source of Truth

The Work Item is the foundational element of the Polarion architecture. Every artefact in the system - requirement, test case, risk record, design specification, hazardous situation, or action item - exists as a Work Item with a unique, persistent identifier. This has profound implications for lifecycle management:

  • Eliminating redundancy: A requirement is defined once and referenced everywhere. There are no duplicate copies in different Word documents that may drift apart over time.
  • Built-in sanity checks: Polarion enforces configurable workflow rules, mandatory fields, and status transitions that prevent incomplete or inconsistent records from advancing through the process.
  • Automatic change propagation tracking: When a single Work Item changes, the impact is immediately visible across all documents and reports that reference it - a critical capability for design change management under FDA QMSR and ISO 13485.

One powerful application is the intended use statement example: rather than copying and pasting this critical regulatory text into multiple documents - where any discrepancy could become an audit finding - teams define it once as a Work Item and reference it everywhere it is needed. Every document that includes it is guaranteed to use the approved, current version.

LiveDocs - Structured Documents with Living Data

Polarion LiveDocs offer a hybrid document experience: the familiar, linear reading format of a Word document, combined with the structured, database-driven power of Work Items. Each paragraph or section within a LiveDoc can itself be a Work Item, meaning it inherits all the version control, linking, and traceability properties of the underlying platform.

This architecture is particularly well-suited to regulated medical device documents such as:

  • Standard Operating Procedures (SOPs) and their templates
  • Software Requirements Specifications (SRS)
  • System Design Specifications
  • Risk Management Plans and Reports (per ISO 14971)
  • Verification and Validation Protocols and Reports
  • Technical Documentation components

For example, acceptance criteria defined in a Validation Plan can be directly referenced as Work Items in the corresponding Validation Report, ensuring full consistency without copy-paste. This is a huge advantage, since any disconnect or human error can be prevented.

LiveDocs can be approved electronically with time-stamped signatures, satisfying both FDA 21 CFR Part 11 requirements for electronic records and EU MDR/IVDR expectations for controlled documentation. Documents do not need to be static exports; they remain live, always reflecting the current state of the linked Work Items.

Excel-Like Sheets - Familiar Interface, Structured Data

One persistent challenge in regulated industries is user adoption. Many engineers and quality professionals are used to work with Microsoft Excel and resist moving to tools that feel bureaucratic or difficult to administer.

In software development teams, tools from Atlassian - particularly Jira for issue and sprint tracking and Confluence for documentation - are widely used and well accepted. However, these tools are not designed for the compliance demands of regulated medical device development, lacking native traceability chains, electronic signatures, and audit trail depth that ALM platforms such as Polarion provide.

Polarion maintains familiarity with Excel through interactive, spreadsheet-style views that allow users to browse, edit, and analyze Work Items in a tabular format without leaving the structured data environment.

This capability is further extended by the Nextedy RISKSHEET plugin [3], which brings genuine Excel-like interactivity to risk management - sorting, filtering, copy/paste, and live editing - directly to Polarion data. Unlike a static Excel export, RISKSHEET operates natively within Polarion: all changes are version-controlled, all links are maintained, and the data is never disconnected from the underlying ALM system.

For risk management specifically, interactive tables allow teams to manage hazards, hazardous situations, risk levels, control measures, and residual risk with the familiar row-and-column experience of a spreadsheet, but with the traceability and audit trail of a regulated ALM platform.

Work Item Links - Automatic Traceability

Traceability is the inherent result of how the platform operates. Because all artifacts are Work Items and every Work Item can be linked to others via defined link roles (e.g., "implements," "verifies," "mitigates," "is derived from"), a complete traceability matrix emerges automatically as the project progresses.

This end-to-end traceability spans the full medical device development:

  • User Needs to System Requirements to Software Requirements
  • Software Requirements to Software Design Specifications
  • Requirements to Test Cases to Test Results
  • Hazardous Situations to Risk Control Measures to Verification of Controls

Regulators - whether FDA inspectors or Notified Body auditors - expect this traceability to be demonstrable on demand. In a Polarion-managed project, generating a traceability report is a matter of configuring a query or a LiveReport page, rather than manually assembling a cross-reference table from multiple documents.

Regulatory Context: Why This Matters

Design Controls and the DHF

The FDA's Quality System Regulation (21 CFR Part 820) and its successor, the Quality Management System Regulation (QMSR) aligned with ISO 13485, require manufacturers to maintain records demonstrating that the design was developed in accordance with the approved design plan. Under traditional document management approaches, the DHF was assembled at the end of development by collecting records from multiple systems - a time-consuming, error-prone process.

In a Polarion-managed development process, the Technical Documentation or Design & Development File is effectively built continuously as work progresses. Every approved requirement, test result, design review record, and risk management output is already version-controlled, linked, and auditable within the system. The regulatory documents become a structured reference into a living database rather than a folder of static files.

Risk Management in Polarion: A Rare but Powerful Application

Risk management per ISO 14971 is one of the most documentation-intensive processes in medical device development. It requires the systematic identification of hazards, hazardous situations, estimation and evaluation of associated risks, definition and implementation of control measures, and monitoring of residual risk - all with full traceability from the initial hazard to the final verification of the control measure.

Polarion is well-suited to this process because the relationships between risk management elements - Harm, Hazardous Situation, Risk Record, Control Measure, Verification - map directly to linked Work Items. The data model can be structured to reflect the ISO 14971 process flow, with each element represented as a configurable Work Item type and the relationships enforced by defined link roles. Also cybersecurity risk management can be implemented in a similar fashion in Polarion.

Despite this natural fit, I have noticed the use of Polarion for risk management remains relatively rare in practice. Most implementations encountered in the field use it primarily for requirements and test management, leaving risk management in standalone Excel files or Word documents. This means a disconnected, error-prone approach. Polarion is well suited for this purpose, as I have experienced in my work with one of our clients.

Tailoring Polarion for the Medical Device Industry

Out of the box, Polarion is a highly capable but deliberately generic platform. Medical device manufacturers working in regulated environments benefit significantly from tailored configurations that align the tool with specific standards, company processes, and regulatory expectations. This tailoring work - defining Work Item types, link roles, workflows, document templates, and reporting widgets - is where specialized consulting partners add substantial value.

Below are two examples:

Reqonsult

ReQonsult GmbH [2], based in Germany, is a certified Siemens Digital Industries Software service partner with expertise in Polarion configuration and integration. ReQonsult develops custom extensions - plugins, servlets, and scripts - and provides consultation, training, support, and performance optimization services tailored to the specific needs of each organization.

Nextedy

Nextedy [3] is a developer of Polarion add-ons and extensions, with a product portfolio specifically designed to enhance the usability and power of Polarion in regulated environments.

Key products relevant to the medical device industry include:

  • Nextedy RISKSHEET: An Excel-like interface that transforms Polarion LiveDocs into dynamic Hazard Analysis and Risk Assessment workbenches, enabling organizations to implement fully ISO 14971-compliant risk management with traceability.
  • Nextedy POWERSHEET: A live, editable Requirements Traceability Matrix (RTM) that provides Excel-like interaction for Polarion data - including unlimited hierarchy depth, cross-domain linking, and built-in data governance - without any external storage or data synchronization.

The Case for a Unified Lifecycle ALM

The traditional medical device development toolchain is fragmented: requirements in Word, test management in Excel, tickets in Jira, risk management in a dedicated FMEA spreadsheet, project tracking in a project management application, and documents stored in a document management system. Each handoff between these tools is a potential source of error, inconsistency, or compliance gap.

Polarion could be a candidate for a single, unified ALM environment where:

  • Every artefact is version-controlled from creation to obsolescence
  • Every relationship between artefacts is explicit, queryable, and reportable
  • Every change is logged with full audit trail
  • Every document is live, linked, and always current
  • Every compliance report can be generated automatically from the underlying data

The biggest hurdles and risks I consider are:

  • Legacy systems: Replacing and combining existing island solutions by migration to Polarion is a major project with high risks and up-front investments.
  • Migration: Process mapping and data transition to Polarion is a major undertaking.
  • Commitment by all stakeholders: Difficulty to get the buy-in from all departments.
  • Polarion Platform alone is insufficient: extensive integration of plug-ins or even tailored solutions by 3rd party companies increases risk of failure, delay and budget overdraw.
  • Administration: If Polarion is run as an on-prem server solution a special IT team has to administer the system, managing risks associated with unavailability, possible data loss, misconfiguration or compatibility issues.

Conclusion

Siemens Polarion ALM represents a mature, powerful platform for managing the lifecycle of medical device development. Its Work Item architecture, LiveDoc capability, spreadsheet-style interactive views, and inherent traceability through Work Item links provide a structural foundation that directly addresses the redundancy, human error, and compliance burden inherent in traditional document-centric development approaches.

For medical device professionals evaluating their ALM strategy, the question is how much of that capability the organization is prepared to invest in realizing.

References

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