Produktivitätsverlust durch manuelle DHF-Verwaltung

Definition

Industry DHF guidance points out that organising and maintaining DHFs ‘takes a considerable effort’ and is often treated purely as a compliance activity rather than an efficiency opportunity.[2] Design control resources emphasise that all design‑control activities (planning, inputs, outputs, reviews, verification, validation, and changes) must be documented and maintained throughout the lifecycle.[1][3][9][10] Without structured systems, this typically involves engineers and QA personnel manually generating PDFs, updating spreadsheets, cross‑linking documents, chasing signatures, and filing or searching for evidence when preparing submissions or facing audits. For an Australian manufacturer developing a regulated electro‑medical device or active implantable, it is reasonable to estimate that: (i) design engineers spend 150–400 hours per project on documentation and DHF‑related administration, (ii) QA/RA staff spend 250–800 hours per project compiling, reviewing, and maintaining DHFs and associated technical files, based on typical task lists (SOP drafting, documentation reviews, DHF indexing, version control, and audit preparation). At a blended fully loaded cost of around AUD 100/hour for specialised engineering and QA roles, this equates to approximately AUD 40,000–120,000 per new product purely in DHF administrative overhead, much of which can be reduced with integrated eQMS and DHF automation (auto‑versioning, central repositories, electronic signatures, and built‑in traceability).[1][2][3][9][10]

Why This Matters

The Pitch: Australian 🇦🇺 medical equipment manufacturers routinely burn 400–1,200 engineer and QA hours per new device compiling and maintaining DHFs using manual tools. Digital DHF platforms and automated document workflows can recover most of this capacity and shorten time‑to‑market.

Affected Stakeholders

Design Engineers, Systems Engineers, Quality Assurance Specialists, Regulatory Affairs Specialists, R&D Project Managers

Related Business Risks