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  • Risk Management for Medical Devices: ISO 14971:2007

  • Hosted By:
  • ComplianceOnline
  • Start:
  • Tuesday - Oct 08, 2013 10:00 AM
  • End Time:
  • Tuesday - Oct 08, 2013 11:00 AM
  • Location:
  • Online
  • This training on ISO 14971:2007 will help you understand the risk management process for medical devices, including risk analysis, risk evaluation, risk control and post-production information.

    Why Should You Attend:
    Medical device companies are required to implement a risk management program as an integral part of their product development activities. Risk management assessment is utilized to manage hazards and potential hazards throughout the product lifecycle, and is required for regulatory compliance. Known hazards must be eliminated or mitigated to achieve the highest possible level of safety and effectiveness of the product for its intended use. Once a product is marketed, the company is also expected to maintain the risk management program, monitoring for new potential hazards and taking preventive action to lower the probability of harm to stakeholders.
    Learning Objectives:
    Promoting product safety and effectiveness
    Making better project management decisions during product development
    Complying with current standards and regulations
    Overview of basic risk modeling tools
    Promoting quality and customer confidence

    Areas Covered in the Webinar:
    -Risk management regulatory framework and definitions
    -Risk Management Process
    -Risk Modeling
    -Risk Management Plan
    -Risk Analysis Tools
    -Risk Management Assessment Training
    -Risk Management Report
    -ISO 14971 Gap Analysis Checklist

    Who Will Benefit:
    -Quality managers
    -Design engineers, process engineers and manufacturing engineers
    -Internal auditors
    -Personnel or vendors developing medical device software
    -Risk managers
    -Medical device product managers
  • Website:
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