Safety Certification Non-Compliance Fines
Definition
Non-compliance with IEC 62304 prevents TGA approval for medical devices containing software, blocking Australian market entry and causing delayed revenue.
Key Findings
- Financial Impact: AUD 50,000-200,000 per certification cycle in rework and audit costs; market entry delays cost 6-12 months revenue
- Frequency: Per product certification cycle (1-2 years)
- Root Cause: Manual handling of traceability matrices, risk analyses (FMEA/FTA), and verification testing required by IEC 62304 Clause 5-7
Why This Matters
The Pitch: Embedded software firms in Australia 🇦🇺 waste AUD 50,000-200,000 annually on IEC 62304 certification rework. Automation of traceability and risk verification eliminates this risk.
Affected Stakeholders
Software QA Manager, Certification Engineer, Product Owner
Deep Analysis (Premium)
Financial Impact
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Current Workarounds
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Methodology & Sources
Data collected via OSINT from regulatory filings, industry audits, and verified case studies.
Related Business Risks
Rework Costs from Certification Gaps
Certification Audit Preparation Overheads
Unbilled Customisation Services
Rework from Poor Customisation Tracking
Legal Disputes from Poorly Managed Systems
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