Industry Solution

Polarion ALM for
Medical Device Software

Accelerate innovation and automate proof of compliance across the full IEC 62304 software lifecycle — from first requirement to FDA submission, in a single connected system.

IEC 62304 FDA 21 CFR Part 11 FDA 21 CFR Part 820 ISO 14971 EU MDR / IVDR ISO 13485
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IEC 62304 lifecycle traceability chain — Polarion ALM
The Challenge

Complex regulation.
Faster delivery.
No compromises.

Software has become the primary differentiator in medical devices — from Class I wearables to Class III implantable systems. Every competitive pressure to ship faster collides with the non-negotiable requirements of FDA, CE marking, and IEC 62304 compliance.

Disconnected tools — requirements in Word, tests in spreadsheets, defects in JIRA — leave traceability gaps that only surface during inspections. By then, the cost of rework is enormous.

Fragmented Design History File

DHF artefacts scattered across drives and tools make audit preparation a weeks-long fire-drill before every submission.

Broken Traceability Chains

Manual traceability matrices in Excel go stale within days of the next change — every update breaks the chain.

Electronic Signature Gaps

FDA 21 CFR Part 11 demands a compliant e-signature system with non-repudiation. Most tools bolt this on as an afterthought.

Risk Management Silos

ISO 14971 risk analysis kept separate from requirements means design changes never trigger a risk re-assessment automatically.

How Polarion ALM Solves It

Purpose-built for the medical device lifecycle

One connected system from User Needs through post-market surveillance — with compliance evidence generated automatically.

IEC 62304 Lifecycle Templates

Pre-configured software development lifecycle templates aligned to IEC 62304 Class A, B, and C. Workflow-enforced phase gates with electronic approval at each milestone.

FDA 21 CFR Part 11 Compliance

Native electronic signatures with non-repudiation, complete audit trail for every work item change, and automated access control. Passes FDA and notified-body scrutiny out of the box.

End-to-End Traceability

Bidirectional live links from User Needs → System Requirements → Software Requirements → Test Cases → Defects. Traceability matrices generated on demand, never manually maintained.

ISO 14971 Risk Management

Integrated risk management using the ISO 14971 template. Risk items are linked directly to requirements — any design change automatically flags affected risk assessments for review.

Design History File Generation

Generate a complete, structured DHF at any point in development. Live report pages pull from the same data that drives development — no manual document assembly.

Collaboration & DOORS Migration

100% browser-based access for distributed teams. Native ReqIF exchange for supply chain collaboration. Structured migration path from IBM DOORS for teams making the transition.

Standards Coverage

Every standard your submission requires

Corbinsoft configures Polarion to your specific regulatory pathway — not a generic template.

IEC 62304
Medical Device Software LifecycleDefines software development lifecycle requirements for medical device software including safety classification, requirements, design, implementation, and maintenance.
FDA 21 CFR Part 11
Electronic Records & SignaturesFDA regulation governing electronic records and electronic signatures used in regulated pharmaceutical and medical device environments.
ISO 14971
Risk Management for Medical DevicesInternational standard for the application of risk management to medical devices throughout the product lifecycle.
FDA 21 CFR Part 820
Quality System Regulation (QSR)FDA's good manufacturing practice requirements for medical devices, including design controls, corrective actions, and process validation.
EU MDR / IVDR
EU Medical Device RegulationEuropean regulations for medical devices (MDR 2017/745) and in-vitro diagnostics (IVDR 2017/746) requiring comprehensive technical documentation.
ISO 13485
Medical Device QMSQuality management system standard specifically designed for organisations involved in the design, production, and servicing of medical devices.

Ready to streamline your
medical device compliance?

Our specialists have implemented Polarion ALM across 510(k), PMA, and CE marking programmes. Talk to us about your regulatory pathway.

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