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<b>Consulting Services for FDA-Regulated Companies </b> </font>
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	Frequently, being able to discuss challenging situations with someone who has been there before can provide 
	the most cost-effective solution. I have worked with over 50 medical device, Biotech and Pharma companies of
	all shapes and sizes.  My consulting experience can help solve your most pressing challenges.
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	<b>Consulting Services include: </font></b>
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		<li>Review and assessment of existing SOPs and Work Instructions<p>
		<li>Preparation of SOPs and Work Instructions on topics including:<p>
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			<li>Design Control <p>
			<li>Software Development <p>
			<li>Software V&V <p>
			<li>Software Tool Validation <p>
			<li>Configuration Management <p>
			<li>Document Control <p>
			<li>Design Reviews <p>
			<li>Risk Management <p>
			<li>Defect Tracking <p>
			<li>Project Management <p>
			<li>Process Validation <p>
			<li>Computer System Validation <p>
			<li>Part 11 related issues <p>
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		<li>Assessment of software development processes<p>
		
		<li>Assessment of software validation and testing processes<p>
			
		<li>Risk Assessment and Hazard Analysis, including Fault Trees and FMECAs<p>
			
		<li>Software project planning, including task estimation and scheduling<p>
			
		<li>Preparation of software-related information for 510(k) submission<p>
				
		<li>Mentoring of SQA and Quality staff<p>
		
		<li>Assistance in responding to software-related 483 issues<p>
		
		<li>Third party software supplier qualification and management<p>
		
		<li>Third party and off-the-shelf software tool qualification and validation<p>
		
		<li>Configuration management, defect tracking, and corrective action (CAPA)<p>
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	My experience in software engineering, medical device software development, training, and
	auditing, can help identify those aspects of your development process that need to be brought into
	compliance with the regulations, guidance documents, and standards.
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	<b>Working collabratively with your staff, we can develop compliant, cost-effective processes that can help
	achieve your critical business objectives. This approach provides the best return on investment.</b>
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	<A HREF=medicalexamples.html><b>Click here</a> for brief summaries of past consulting engagements.</b>
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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>
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    Updated September 2008</font></p>
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