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<b>Training Services for Biotech and Medical Device Companies</b> </font>
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	Companies developing software in regulated industries must maintain compliance with regulations such
	as the FDA Quality System Regulation as well as standards from organizations such as ISO, IEC, and
	AAMI.
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	Examples of on-site workshops, tailored to meet your specific needs, environment, and products,
	include:<p>
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		<li><A HREF="/training/fda2daycourse.html">
			<b>Software Development for Medical Device Manufacturers</b></a><p>
			Interpret and apply the QSR Design Controls to software development.<p>
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		<li><A HREF="/training/swvvmedical.html"><b>Software V&V</b></a><p>
			Practical skills to increase effectiveness of software verification and	validation.<p>
			
		<li><A HREF="/training/risk1.html"><b>Risk Assessment and Hazard Analysis</b></a><p>
			Learn to perform Risk Assessment for software-based medical devices. Ensure compliance with ISO 14971 and
			take advantage of AAMI TIR-32 Application of Risk Management to Software-based Medical Devices. Learn effective
			techniques such Fault Tree Analysis (FTA) and Failure Mode Effects Criticality Analysis (FMECA).<p>
			
		<li><A HREF="/training/csv.html"><b>Computer System Validation Training</b></a><p>
			Perform effective validation of computer systems used in Manufacturing and Quality Systems.<p>
			
		<li><A HREF="/training/part11.html"><b>21 CFR Part 11 Training</b>g</a><p>
			Learn how to comply with regulation on Electronic Records and Electronic Signatures.<p>
				
		<li><A HREF="/training/process.html"><b>Process Validation Training</b></a><p>
			Perform effective validation of processes used in Manufacturing.<p>
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	Let my experience in software engineering, medical device software development, training, and
	auditing, help identify those aspects of your development process that need to be brought into
	compliance with the regulations and standards.

	<b><p>Working collabratively with your staff, we develop processes that not only are compliant but
	are also cost-effective and make make good business sense... </b>This approach provides the best return
	on investment.
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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 January 2008</font></p>
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