Daber MedTech
Your Partner in Compliance and Operational Continuity.

Compliance & Operational Continuity

Expert consulting, post-market surveillance engineering, data insights, and workforce labour gap coverage tailored strictly for the diagnostic, scientific instrument, and medical device sectors.

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Core Competencies

Consulting Services

Strategic regulatory advisory and validation oversight including Post Market Surveillance Requirements, Vigilance Reporting Guidance, comprehensive Compliance Audit Readiness Strategies and Support layouts.

Data to Actionable Insights

Data structuring, transformation, analysis and interpretation into actionable trending and metrics. Specialising in Special Cause Analysis configurations, operational parameter trending, and structured Six Sigma Process Improvement frameworks.

Field Service Engineering

High-tier field technical operations covering diagnostic and scientific equipment. Providing immediate technical Workforce Labour Gap Coverage and rapid Emergency Field Service Engineer (FSE) Leave Cover support.

Corporate Profile

Daber MedTech delivers specialised technical consulting, data engineering, and field service solutions tailored strictly for the medical device, clinical healthcare, and scientific research sectors.

Our operations bridge the critical gap between complex quality frameworks and day-to-day laboratory performance—ensuring that customer installations remain fully optimised, compliant, and continuously operational.

Business Intelligence & Data Harmonisation

  • Experienced in: Establishing data storage conventions; designing, testing and validating methods for turning this data into convenient dashboards for insertion into Product Safety Update Reports (PSUR), Medical Incident Reporting (MIR) forms, and for decision making.
  • Experienced in: Establishing unified, company-wide standards for mining, analysing, and transforming data hierarchies integrated with global coding frameworks (IMDRF / CI86 (AAMI)).
  • Experienced in: Introducing statistical process control methods to generate live, actionable data analytics, metrics tracking and business balanced scorecards, including special cause detection, and specification / control limits.

Regulatory Compliance & Audit Support

  • Experienced in: Advising and mentoring organisations on efficient, effective audit mechanics to establish stable, defensible regulatory readiness.
  • Experienced in: Coordinating and preparing Post Market Reviews, Management Reviews, and Manufacturing Quality Plans.
  • Experienced in: Preparing documentation and supporting technical teams during external audits conducted by major notified bodies, including the TGA, FDA, TÜV Rheinland, and TÜV Süd.
  • Experienced in: Structuring and maintaining the Post Market Regulatory Response Process and coordinating international product submissions under strict European medical standards (EU-MDR 2017/745).

Field Service Engineering & Workforce Support

  • Experienced in: Providing technical workforce labour gap coverage and emergency Field Service Engineer (FSE) leave cover intervals to maintain operational continuity.
  • Experienced in: Delivering technical support and field asset maintenance, repair and management for medical diagnostic systems and scientific instruments.
  • Experienced in: Coordinating workflow allocations and task priority paths to minimise customer downtime and maximise business continuity.
Company Headquarters

Headquartered in Sydney, Australia.

Registered Entity Operations: ABN 47 997 877 468

Mobility

Providing engineering support and technical services across Australia and beyond. Contact us to discuss your facility's specific location and deployment requirements.

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