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<img src="images/home.gif" alt="Providing a full range of consulting, training, and auditing services for the Medical Device,
BioTech and Pharma Industries." title="Providing a full range of consulting, training, and auditing services for the Medical Device, BioTech and Pharma Industries."/>
<br/>
<h1 align=center>Consulting services to help your organization:</h1>
<br>
<ul class="indent_home">
<ul style="list-style-type: disc;">
<li>Comply with FDA and EU regulations, FDA Guidance documents and International Standards </li>
<li>Develop a compliant and cost-effective Quality Management System </li>
<li>Comply with IEC 62304 Medical Device Software Development Lifecycle </li>
<li>Comply with ISO 14971 Medical Device Risk Management </li>
<li>Auditing to ensure compliance with regs and SOPs </li>
</ul><br>
<br>
<h1 align = center>Training services including:</h1>
<br>
<ul class="indent_home">
<ul style="list-style-type: disc;">
<li>Software Development for Medical Devices </li>
<li>Software Verification and Validation </li>
<li>Risk Management for Medical Devices </li>
<li>Software Tool Validation </li>
<li>Computer System Validation </li>
</ul><br>
<br>
<h1 align = center>Auditing services to help your organization:</h1>
<br>
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<li>Prepare for FDA audits </li>
<li>Assess compliance with internal SOPs </li>
</ul><br/>
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