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<b>Auditing Services for FDA-Regulated Companies</b> </font>
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	Companies developing software as part of a medical device or using software as part of a manufacturing, production, or quality
	system are required to maintain compliance with FDA regulations, guidance documents and standards from organizations such as
	ISO, IEC, and AAMI.
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	<b>Auditing Services </font></b><p>
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	Properly planned audits can identify gaps in your present quality system and
	opportunities for improvements. </b>
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	<p> <b>Examples of typical audits include: </b></font>
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		<li>Design Controls Compliance Audit<p>
		<li>Part 11 Compliance Audit<p>
		<li>ISO 13485 Compliance Audit<p>
		<li>ISO 14971 Compliance Audit <p>
		<li>Quality and Process Audits<p>
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	Each audit begins with an Audit Plan that identifies what, when, where, and who. The Audit Plan is
	reviewed and approved prior to the audit. Members of the client's staff are encouraged to participate
	on the Audit Team. Once the audit is completed, an Audit Report is prepared, and if requested, a
	detailed "gap analysis" is provided.
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	<b>Relevant Audit Experience:</b></font>
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	<li>ASQ Certified Quality Auditor (CQA) since 1994<p>
	<li>ISO 9000 Lead Assessor Training <p>
	<li>SEI CMM Assessor Training <p>
	<li>Lead Auditor on dozens of audits covering Development and Manufacturing<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>Click here</a> for brief summaries of past consulting engagements.
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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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