Delivering in-house training in ISO 13485, Medical Devices- Quality Management Systems-Requirements for Regulatory Purposes Call Rachel McLean +44(0)1292 671555

 

ISO 13485

One Day Awareness Workshop Contents
This workshop requires some understanding of Quality Management Systems and is designed for personnel who wish to gain further knowledge of how regulatory requirements are addressed using the ISO13485 Standard. The key topics covered are:

  • Process Model & limitations

  • Key Regulatory Requirements to be addressed

    • EC Medical Device Directives

    • FDA CFR 820

    • Health Canada CMDCAS

  • Quality System Requirements & Processes

  • Management Processes

  • Resourcing Processes

 

  • Product Processes

    • Design

    • Purchasing

    • Manufacturing

    • Environment Control

    • Installation  / servicing

    • Process Validation

    • Traceability

  • Measurement, Analysis & Improvement Processes

 

Call Rachel McLean on +44(0)1292 671555 or email rachel@gpb.ltd.uk to discuss your needs.

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