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<a href="training_medical.html"><img src="images/arrow_back.gif" /> back to Training for the Medical Device Industry
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<h1>Risk Management for Medical Device Manufacturers </h1>
Many medical device manufacturers may find it difficult to perform Risk Management when software is embedded within
their medical device OR when software IS the medical device.
This course can help your organization learn effective techniques for performing Risk Management
on devices with embedded software. In addition, this course will illustrate ways to integrate Risk Management
activities throughout your Quality Management System (QMS).<br/><br/>
You will learn to apply <span class="bold">powerful</span> tools such as:<br/>
<ul class="indent">
<li><span class="bold">Fault Tree Analysis (FTA)</span></li>
<li><span class="bold">Failure Modes Effect and Criticality Analysis (FMECA)</span> </li>
<li><span class="bold">Software Reliability Growth Modeling</span></li>
</ul><br/>
This course can help identify areas of potential regulatory exposure. By applying the principles learned in this course,
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.<br/> <br/>
<img src="images/risk.gif" alt="risk chart" title="risk chart" /><br/><br/>
<h2>Topics covered include: </h2><br/>
<span class="bold">Risk Management Overview </span><br/>
<ul class="indent">
<li>Overview of Regulatory Requirements and Standards including: ISO 14971, IEC 62304, and ISO/TR 80002-1</li>
</ul><br/>
<span class="bold">Risk Concepts and Terminology</span>
<ul class="indent">
<li>Risk Assessment </li>
<li>Identifying Known or Foreseeable Hazards </li>
<li>Estimating Risk </li>
</ul><br/>
<span class="bold">Risk Control Techniques </span>
<ul class="indent">
<li>Inherently Safe Design </li>
<li>Hazard Detection </li>
<li>Information for Users </li>
</ul><br/>
<span class="bold">Risk Management Tools </span>
<ul class="indent">
<li>Fault Tree Analysis: The top-down approach </li>
<li>Failure Mode Effects Criticality Analysis (FMECA) </li>
<li>System Hazard Analysis using Fault Trees and FMECAs </li>
<li>Verification and Validation of Mitigations</li>
</ul><br/>
<span class="bold">Exercise: Fault Tree Analysis </span>
<span class="bold">Integrating Risk Management into the QMS </span>
<ul class="indent">
<li>Risk Management File</li>
<li>Measuring Software Reliability Growth</li>
</ul><br/>
<h2>Tailoring </h2>
This course can be tailored to meet your specific needs.
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