Fragmented DHF evidence
Design records scattered across drives and tools make submission preparation slow and error-prone.
Industry Solution
Polarion ALM for Medical Device Software
Accelerate innovation and automate proof of compliance across IEC 62304, ISO 14971, FDA design controls, and post-market software maintenance.
The Challenge
Faster medical innovation without compliance shortcuts.
Medical device teams must ship safe software while proving design controls, risk management, verification, validation, and electronic records compliance.
Broken traceability matrices
Manual Excel matrices go stale as requirements, risks, tests, and defects change.
Risk management silos
ISO 14971 risk records separated from requirements make design impact analysis unreliable.
How Polarion Helps
Purpose-built for controlled medical software development.
Polarion keeps regulatory evidence connected to the engineering work that creates it.
- IEC 62304-aligned lifecycle workflows for Class A, B, and C software.
- FDA 21 CFR Part 11-style electronic signatures, access controls, and audit trails.
- Live links from user needs to requirements, risks, test cases, defects, and release evidence.
- ISO 14971 risk items linked directly to design controls and mitigations.
- LiveReports for DHF, traceability matrices, verification status, and release readiness.
Standards Coverage
Every standard your submission depends on.
IEC 62304
Software lifecycle processes for planning, requirements, architecture, design, implementation, verification, and maintenance.
ISO 14971
Risk management integrated with requirements, mitigations, verification, and review workflows.
FDA 21 CFR Part 11
Electronic records and signatures with accountable approvals and change history.
FDA 21 CFR Part 820
Design controls, corrective actions, and validation evidence for quality systems.
EU MDR / IVDR
Technical documentation and traceability evidence for medical and diagnostic products.
ISO 13485
Quality management processes for medical device design, production, and servicing.
Ready to streamline medical device compliance?
Radax can help build Polarion templates, validation reports, risk workflows, DHF reports, and migration plans.