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<TITLE>Software Development for Medical Device Manufacturers - Two 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">Two Day Workshop </b>
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Many medical device manufacturers find it difficult to develop software
in compliance with FDA QSR regulations and international standards such as ISO 14971, ISO 13485, ISO 62304 and
other emerging standards. This <b>two-day comprehensive</b>
workshop will provide your organization with practical guidance and recommendations
for a <b>software development process </b> that complies with FDA QSR, FDA Guidance documents,
applicable international standards in a manner that is <b>flexible, cost-effective, and
makes good business sense...</b></font>
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<p align="LEFT"><b>Topics covered in the two-day workshop:</b></font>
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<li><b>Introduction </b>
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<li>FDA Regulations and Guidance Documents
<li>Review and Discussion of International Standards and Technical Reports
<li>Five Types of Medical Device Software Regulated by FDA
<li>Medical Device Documentation: Procedures, Work Instructions and Records
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<li><b>Interpreting Design Controls for Software</b>
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<li>Review of All Design Control (820.30) Sections from Software Perspective
<li>Software Development Models
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<li><b>Software Verification Process</b>
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<li>About Requirements�
<li>Unit and Integration Testing
<li>Design Reviews
<li>Verification Exercise...
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<li><b>Software Validation Process</b>
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<li>Testing Overview
<li>Testing Levels, Methods, and Types
<li>Test Planning
<li>Testing Measures
<li>Common Testing Problems
<li>Validation Exercise...
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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
<li>Fault Tree Exercise
<li>Data Collection and Analysis
<li>Documentation Requirements
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<li><b>Validation of Software Tools Used to develop Device Software</b><p>
<li><b>Validation of Software Used in Manufacturing and Quality Systems</b>
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<li><b>Summary</b>
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The focus of this two-day course is on interpreting FDA Regulations and Standards for Medical Device
Software. Specifically, the course includes a comprehensive discussion of Design Controls and how they can be
interpreted for medical device software<p>
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<b>Topics discussed in depth include:</b><p>
<ul type=bullet>
<li>Software Development Process<p>
<li>Design Reviews for Software <p>
<li>Software Validation Testing<p>
<li>Risk Management Techniques based on ISO 14971<p>
<li>Validation of Software Development Tools<p>
<li>Validation of Software used in Quality Systems and Manufacturing<p>
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To help reinforce critical skills related to risk management, several interactive exercises are
included in the workshop. In addition, examples of cost-effective processes and procedures that meet the regulations and comply
with applicable standards are discussed.<p>
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<b>Tailoring</b>
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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.<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 �2009 Software Quality Consulting, Inc. All rights reserved.<br>
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Updated July 2009</font></p>
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