Design Control and Risk Management
built for audit — not built around the audit.
Design Control is one of the most inspection-scrutinized areas of medical device compliance. Requirements, risks, tests, and design history — each in a different tool, with manual traceability maintained by people who can't keep up with change velocity. We put the entire design lifecycle in Polarion — and automate the evidence trail that follows every change.
When the auditor asks for end-to-end traceability from user need to validated test, assembling that evidence from disconnected spreadsheets, Word documents, and legacy tools can take days. With Polarion + Compliance Group's preconfigured Design Control, that evidence is assembled in minutes — automatically updated with every change.
What Design Control looks like when traceability is automated, not assembled.
End-to-end traceability assembled automatically
Every requirement, risk, test, and design history record linked in Polarion. Traceability matrices update automatically with every change. Inspection evidence assembled in minutes.
Risk management that scales with the device
ISO 14971-aligned risk management connected to design control — risk assessments update automatically when requirements change.
50–80% reduction in Design Control effort
Preconfigured workflows, automated artifact generation via CLAiRE AI Agentic Platform, and intelligent reuse compress design lifecycle documentation effort.
SaMD programs on audit-ready foundations
Software as a Medical Device programs built under IEC 62304, EU MDR, and FDA's AI/ML framework — with AI governance integrated from day one via CLAiRE.
Design control managed in spreadsheets creates traceability gaps, audit delays, and compliance risk.
Despite being mandated by 21 CFR 820 and EU MDR/IVDR, most medical device organizations still manage design control in a combination of spreadsheets, Word documents, and legacy requirements tools not designed for regulated environments.
Traceability matrices outdated the moment they're created
Every change to a requirement, risk, or test invalidates some portion of your traceability matrix. Manual maintenance can't keep pace.
Risk assessments aren't connected to requirements
Your risk assessment lives in a spreadsheet. Your requirements live in a Word document. When a requirement changes, someone has to remember to update the risk assessment. Sometimes they don't.
Design history files are assembled, not maintained
The DHF is created before each major milestone or inspection. Between milestones, underlying records drift. The assembly effort consumes weeks.
EU MDR/IVDR creates new obligations most teams haven't addressed
Post-Market Surveillance integration, clinical evaluation linkage, and full technical documentation requirements under EU MDR are fundamentally different from the legacy 510(k) approach.
SaMD programs lack IEC 62304-aligned infrastructure
Software as a Medical Device programs require software lifecycle documentation, anomaly tracking, and change management under IEC 62304 — most teams build this on top of development tools not designed for compliance.
AI/ML features create new risk management requirements
FDA's AI/ML action plan creates specific risk management obligations for AI-enabled medical devices. ISO 14971 applies to the AI layer. Most device risk programs haven't been extended to cover it.
Polarion-based Design Control and ISO 14971 risk management — accelerated by CLAiRE.
Polarion-Based Design Control Implementation
Preconfigured Polarion ALM with Design Control templates, workflows, and compliant SOPs aligned to 21 CFR 820, EU MDR/IVDR, ISO 13485, and GAMP 5 Second Edition. Automated end-to-end traceability. 50% reduction in requirements authoring, 80% reduction in traceability management effort.
ISO 14971 Risk Management Programs
End-to-end risk management aligned to ISO 14971 — hazard identification, risk estimation, evaluation, and control — connected to your Design Control traceability in Polarion. Risk assessments update automatically when requirements change.
CLAiRE AI Quality Reviews for Design Documentation
CLAiRE AI Agentic Platform's Quality Review capability automatically reviews design documentation for completeness and traceability against requirements — reducing Review & Approval cycle time by up to 40%.
AI Test Management generates CSA-aligned test cases directly from Polarion requirements. CLAiRE AI Agentic Platform Quality Reviews validate documentation completeness automatically.
Book a Free AI Readiness Assessment.
45 minutes with a senior expert—not a sales rep. Written risk brief included. No commitment. You walk away knowing exactly where your biggest regulatory exposure sits.
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