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Course Outline
  • Overview
  • General Requirements for Risk Management
  • Risk Analysis
    • Risk Management Techniques
    • Characteristics related to Safety of Medical Device
    • Identify of Hazards
    • Estimation of Risks
  • Risk Evaluation
  • Risk Control
  • Evaluation of Residual Risk
  • Risk Management Report
  • Production & Post Production Information
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ABOUT US

We are an established advisory firm in Systems Assurance and Regulatory Compliance. Specialize in helping our clients to institutionalize simple, effective and integrated system which TRANSCEND the conventional functional boundaries, by bringing peoples and processes together. 

System Assurance

A good system assures the consistency of the resulting products and services. We customize, adopt and integrate international recognized standards based Management Systems into the existing operating model and organizational context of our clients.  

Regulatory Compliance

Products related regulatory has becoming the new challenge for placing a product in the global market.  We provide valuable supports for organizations to compliance with the essential safety and performance requirements for the intended uses of their products.

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