Kosten durch mangelhafte Rückverfolgbarkeit in Design History Files

Definition

DHF guidance emphasises that the file must contain or reference all records needed to demonstrate that the device design was developed according to the approved plan, including design reviews, verification, validation, and risk‑management outputs.[1][2][3][9] ISO 13485 design‑and‑development files likewise require comprehensive records of design inputs/outputs, review, verification and validation, plus changes.[3][5] In practice, gaps in traceability between requirements, design outputs, and test evidence often appear when documents are stored in silos or maintained manually; industry DHF blogs note that compiling DHFs often requires ‘considerable effort’ and that processes are rarely optimised for efficiency.[2] When traceability is unclear, quality and engineering teams must: (i) manually reconstruct requirement‑to‑test mappings, (ii) commission additional bench, biocompatibility, or software tests to close perceived gaps, and (iii) repeat verification or validation after design changes because historical evidence cannot be reliably linked. For a typical Australian medium‑size manufacturer, each significant design‑verification or validation campaign (including protocol development, test execution, and reporting) can logically cost in the range of AUD 20,000–80,000 in internal labour and external lab fees per subsystem or major design change, especially for devices requiring performance, EMC, or software validation. When two to three such campaigns must be repeated or expanded over a device’s lifecycle due to DHF and traceability issues, avoidable spend amounts to approximately AUD 50,000–200,000 per product line. Additional soft costs include extended time to implement design improvements and slower response during complaint investigations, which may in turn increase the risk of field actions and associated costs.[1][2][3][5][9][10]

Why This Matters

The Pitch: Medical device manufacturers in Australia 🇦🇺 unnecessarily spend AUD 50,000–200,000 per affected product on repeated verification/validation studies and engineering rework caused by gaps in DHF traceability. Implementing structured, digital DHF traceability matrices and integrated change control avoids most of this waste.

Affected Stakeholders

Design & Development Engineers, Verification & Validation Engineers, Quality Assurance Engineers, Regulatory Affairs Specialists, Project Managers for new product development

Related Business Risks