Delivering in-house training in ISO 14971:2007 Medical Devices-Application of Risk Management Call Rachel McLean +44(0)1292 671555

 

ISO 14971:2009

One Day Awareness Workshop Contents
This workshop requires an appreciation of Hazard and Risk and is designed for delegates who wish to gain further knowledge of the models and techniques used to assess hazards and manage risks as defined in the new ISO14971:2009 Standard. The key topics covered are:

  • Scope

  • Definitions

  • Requirements

    • Risk Management Process

    • Management Responsibility

    • Qualification of Personnel

    • Risk Management Plan

    • Risk Management File

  • Risk Analysis

    • Risk Analysis Process

    • Intended Use /Characteristics Identification

    • Identification of Hazards

    • Estimation of Risk for Each Hazard / situation

    • Risk Evaluation

 

Procedural Requirements & Link to ISO13485 & CFR820

  • Device Indications for Use Characteristics

  • Hazard Identification Tools & Techniques

  • Estimation of Risks for each hazards

 Evaluation of Overall Residual Risk Acceptability

  • Risk Management Report

  • Production and Post Production Information

    • Analysis of Feedback

    • Design / process / specification changes

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

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