Überhöhte interne Kosten für manuelle Bearbeitung von Beschwerden und MDR‑Bewertungen

Definition

ARGMD and TGA’s regulatory framework require sponsors and manufacturers to maintain robust post‑market monitoring, including risk assessment and investigation of medical device adverse event and complaint reports and maintaining technical documentation.[5][4] Typical complaint-handling processes have multiple phases—intake, investigation, and closure—each requiring data capture, assessment of reportability, and potentially preparation of vigilance reports or recall documentation.[2][4] When these steps are executed with manual tools (email, spreadsheets, disconnected databases), RA/QA specialists often spend several hours per complaint on information gathering, classification, and documentation to meet TGA expectations, including traceability to risk management files and CAPA where necessary.[2][5] Assuming a blended RA/QA labour cost of AUD 80–120 per hour in Australia, and 10–15 hours of effort for complex or potentially reportable complaints (intake clarification, investigation coordination, MDR assessment, documentation, and management review), the internal cost per escalated complaint easily reaches AUD 800–1,800. For a mid‑size manufacturer handling 150–300 such complaints annually, this results in AUD 120,000–540,000 in internal overhead, a significant portion of which is avoidable with workflow automation, integrated data capture, and MDR decision support (logic extrapolated from standard labour costing applied to the complaint workflow described in industry guidance).

Why This Matters

The Pitch: Medical device manufacturers in Australia 🇦🇺 routinely spend AUD 1,000–2,000 in internal labour per escalated complaint on manual MDR assessment and documentation. Automating intake, classification, and reporting can cut this by 30–50%, saving tens of thousands annually.

Affected Stakeholders

Quality Assurance Specialist, Regulatory Affairs Specialist, Post‑Market Surveillance Manager, Customer Service/Technical Support, Head of Quality

Related Business Risks