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<TITLE>Software Development for Medical Device Manufacturers - One day course</TITLE>
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<b>Training</b> </font>
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<b>Software Development for Medical Device Manufacturers
<p align="center">One Day Workshop</b>
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Many medical device manufacturers find it difficult to develop software in compliance with FDA QSR regulations,
FDA Guidance documents and applicable international standards.
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Both a <b>one-day</b> and <b>two-day</b> workshop are available that provide your organization with
practical guidance and recommendations for a <b>software development process </b>
that not only complies with regulations in the QSR, ISO 14971, and ISO 13485, but
is <b>flexible, cost-effective, and makes good business sense...</b></font>
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<p align="LEFT"><b>Topics covered in the one-day workshop:</b></font>
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<li><b>Introduction </b>
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<li>FDA Regulations and Guidance
<li>International Standards and Technical Reports<p>
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<li><b>Interpreting Design Controls for Software</b>
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<li>Software Development Models
<li>About Requirements�
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<li><b>Software Verification Process</b>
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<li>Design Reviews
<li>Unit and Integration Testing
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<li><b>Software Validation Process</b>
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<li>Testing Overview
<li>Testing Levels, Methods and Types
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<li><b>Risk Management for Software-Based Medical Devices</b>
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<li>Standards and Regulations
<li>Terms and Concepts
<li>Risk Management Process
<li>Risk Management Tools and Techniques for Software-based Devices
<li>Fault Tree Exercise
<li>Data Collection and Analysis
<li>Documentation Requirements
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<li><b>Summary</b>
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This workshop provides specific examples of processes and procedures that meet the FDA regulations and
allow work to be performed in a flexible and cost-effective manner...
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To help reinforce critical skills, this workshop includes an interactive exercise on Risk Management...
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<b>Tailoring</b>
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Both of these workshops 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.<p>
Call for details...
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<b>For further information,
<p>call Steve Rakitin at <font size="3" color=Red face="Arial">508.529.4282</font>
<p><font size="3" color=Black face="Arial">or e-mail him at
<a href="mailto:[email protected]"><b>[email protected]</a></b><p><br>
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Food for Thought and Predictable Software Development are trademarks of Software Quality Consulting, Inc.<br>
Copyright �2008 Software Quality Consulting, Inc. All rights reserved.<br>
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Updated September 2008</font></p>
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