Rework Costs from Certification Gaps
Definition
Standards require linking every requirement to tests/designs; failures trigger expensive late-cycle fixes.
Key Findings
- Financial Impact: AUD 20,000-100,000 per project in rework (20-40 hours/week x AUD 150/hr for 3-6 months)
- Frequency: Every major release or certification audit
- Root Cause: Lack of automated traceability matrix as required by IEC 62304 Clause 5.2.6 and ISO 26262
Why This Matters
The Pitch: Embedded software developers in Australia 🇦🇺 lose AUD 20,000-100,000 per project on late-stage IEC 62304 rework. Automated traceability tools cut this by 80%.
Affected Stakeholders
Embedded Software Engineer, QA Lead, Compliance Officer
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
Safety Certification Non-Compliance Fines
Certification Audit Preparation Overheads
Unbilled Customisation Services
Rework from Poor Customisation Tracking
Legal Disputes from Poorly Managed Systems
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