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Training


Risk Analysis for Medical Device Manufacturers

Many medical device manufacturers may find it difficult to perform Risk Management when software is embedded within their medical device. This workshop can help your organization learn effective techniques for performing Risk Management on devices with embedded software. In addition, this workshop will illustrate ways to integrate Risk Management activities throughout your Quality Management System (QMS)

You will learn to apply powerful tools such as:

  • Fault Tree Analysis (FTA)

  • Failure Modes Effect and Criticality Analysis (FMECA)

  • Failure Reporting and Corrective Action System (FRACAS)

This workshop can help you identify areas of potential regulatory exposure. By applying the principles learned in this workshop, you'll be able to improve the effectiveness of your development activities, measure and improve product reliability, minimize the likelihood of potentially costly product recalls, and significantly reduce rework and product maintenance costs.


riskoverview

Topics covered include:

  • Risk Management Overview
    • Overview of Regulatory Requirements and Standards
    • ISO 14971, ISO 13485, and IEC 60601-1-4

  • Risk Concepts and Terminology
    • Risk Assessment
    • Identifying Known or Forseeable Hazards
    • Estimating Risk

  • Risk Control Technques
    • Inherently Safe Design
    • Detection
    • Documentation

  • Risk Management Tools
    • Fault Tree Analysis: The top-down approach
    • FMECAs: A complement to Fault Trees
    • System Hazard Analysis using Fault Trees and FMECAs

  • Exercise: Fault Tree Analysis

  • Integrating Risk Management into the QMS
    • Verification and Validation
    • Using FRACAS to Measure Reliability Growth
    • Risk Management File

  • Summary and Action Plan


Tailoring

tailor This workshop can be tailored to meet your specific needs. By reviewing your Quality Manual and relevant SOPs, an assessment of your current Quality System and how it meets (or doesn't meet) the regulations and standards can be provided as part of the workshop.

Call for details...




For further information,

call Steve Rakitin at 508.529.4282

or e-mail him at steve@swqual.com


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Copyright ©2008 Software Quality Consulting, Inc. All rights reserved.

Updated January 2008