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ISO13485 Consultancy Services

Services include:-

  • System set-up, implementation and ongoing maintenance.

  • System Upgrades - for ISO13485:2016 transition - from gap analysis to full system development and support.

  • General Training - for senior managers, middle managers, supervisors and staff, quality representatives and internal auditors.

  • Specific Training - for ISO13485 related tools and techniques, e.g. PESTLE and SWOT analysis, strategy, performance measurement, systems thinking, human factors, risk based thinking, risk management, FMEA, APQP, SPC, etc.

  • CE compliance support.

  • Audit - independent audit conducted of your business to ensure ongoing compliance, effectiveness and risk mitigation.

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