<h3><span style="font-size:20px"><span style="font-family:Arial,Helvetica,sans-serif"><strong>Master the Art of Auditing Medical Device Quality Management Systems</strong></span></span></h3>

<p><span style="font-size:14px"><span style="font-family:Arial,Helvetica,sans-serif"><strong>Our ISO 13485:2016 Lead Auditor Training is a comprehensive course that equips participants with the skills and qualifications to audit Medical Device Quality Management Systems (MDQMS) in accordance with ISO 13485 standards and the guidelines of ISO 19011 and ISO/IEC 17021.</strong></span></span></p>

<p><span style="font-size:14px"><span style="font-family:Arial,Helvetica,sans-serif"><strong>Designed for professionals in the medical device industry, this training prepares you to lead audits that ensure compliance with international regulatory and quality requirements.</strong></span></span></p>

<h3><span style="font-size:20px"><span style="font-family:Arial,Helvetica,sans-serif"><strong>Key Learning Objectives</strong></span></span></h3>

<ul>
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	<p><span style="font-size:12px"><span style="font-family:Arial,Helvetica,sans-serif"><strong>In-depth understanding of ISO 13485:2016 standard</strong></span></span></p>
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	<p><span style="font-size:12px"><span style="font-family:Arial,Helvetica,sans-serif"><strong>Structure and requirements of MDQMS</strong></span></span></p>
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	<p><span style="font-size:12px"><span style="font-family:Arial,Helvetica,sans-serif"><strong>Risk-based thinking in medical device manufacturing</strong></span></span></p>
	</li>
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	<p><span style="font-size:12px"><span style="font-family:Arial,Helvetica,sans-serif"><strong>Principles and techniques of auditing</strong></span></span></p>
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	<p><span style="font-size:12px"><span style="font-family:Arial,Helvetica,sans-serif"><strong>Audit planning, execution, reporting &amp; follow-up</strong></span></span></p>
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	<p><span style="font-size:12px"><span style="font-family:Arial,Helvetica,sans-serif"><strong>Performing audits based on ISO 19011 guidelines</strong></span></span></p>
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	<p><span style="font-size:12px"><span style="font-family:Arial,Helvetica,sans-serif"><strong>Regulatory relevance with MDR, FDA 21 CFR Part 820, and more</strong></span></span></p>
	</li>
</ul>

<h3><span style="font-size:20px"><span style="font-family:Arial,Helvetica,sans-serif"><strong>Who Should Attend?</strong></span></span></h3>

<ul>
	<li>
	<p><span style="font-size:14px"><span style="font-family:Arial,Helvetica,sans-serif"><strong>Quality Managers &amp; Regulatory Affairs Professionals</strong></span></span></p>
	</li>
	<li>
	<p><span style="font-size:14px"><span style="font-family:Arial,Helvetica,sans-serif"><strong>Internal Auditors in Medical Device Companies</strong></span></span></p>
	</li>
	<li>
	<p><span style="font-size:14px"><span style="font-family:Arial,Helvetica,sans-serif"><strong>Compliance Officers and Quality Assurance Teams</strong></span></span></p>
	</li>
	<li>
	<p><span style="font-size:14px"><span style="font-family:Arial,Helvetica,sans-serif"><strong>Consultants and Certification Body Auditors</strong></span></span></p>
	</li>
	<li>
	<p><span style="font-size:14px"><span style="font-family:Arial,Helvetica,sans-serif"><strong>Anyone aspiring to become a certified ISO 13485 Lead Auditor</strong></span></span></p>
	</li>
</ul>

<h3><span style="font-size:20px"><span style="font-family:Arial,Helvetica,sans-serif"><strong>Certification &amp; Recognition</strong></span></span></h3>

<p><span style="font-size:14px"><span style="font-family:Arial,Helvetica,sans-serif"><strong>Successful candidates will receive an internationally recognized ISO 13485:2016 Lead Auditor Certificate from an accredited certification body. This qualification allows you to lead internal, supplier, and third-party audits for medical device quality systems.</strong></span></span></p>

<h3><span style="font-size:22px"><span style="font-family:Arial,Helvetica,sans-serif"><strong>Training Details</strong></span></span></h3>

<ul>
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	<p><span style="font-size:14px"><span style="font-family:Arial,Helvetica,sans-serif"><strong>Duration: 5 Days</strong></span></span></p>
	</li>
	<li>
	<p><span style="font-size:14px"><span style="font-family:Arial,Helvetica,sans-serif"><strong>Format: Classroom / Live Online / On-Site Training</strong></span></span></p>
	</li>
	<li>
	<p><span style="font-size:14px"><span style="font-family:Arial,Helvetica,sans-serif"><strong>Trainer: Certified auditors with medical device industry expertise</strong></span></span></p>
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	<p><span style="font-size:14px"><span style="font-family:Arial,Helvetica,sans-serif"><strong>Materials: Course manual, audit checklist templates, real-life case studies</strong></span></span></p>
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	<p><span style="font-size:14px"><span style="font-family:Arial,Helvetica,sans-serif"><strong>Evaluation: Written exam + continuous assessment during training</strong></span></span></p>
	</li>
</ul>

<h3><span style="font-size:20px"><span style="font-family:Arial,Helvetica,sans-serif"><strong>Why Choose Our Training?</strong></span></span></h3>

<ul>
	<li>
	<p><span style="font-size:14px"><span style="font-family:Arial,Helvetica,sans-serif"><strong>Globally recognized and accredited training provider</strong></span></span></p>
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	<p><span style="font-size:14px"><span style="font-family:Arial,Helvetica,sans-serif"><strong>Expert trainers with regulatory and audit experience</strong></span></span></p>
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	<p><span style="font-size:14px"><span style="font-family:Arial,Helvetica,sans-serif"><strong>Industry-focused examples for practical understanding</strong></span></span></p>
	</li>
	<li>
	<p><span style="font-size:14px"><span style="font-family:Arial,Helvetica,sans-serif"><strong>Custom training available for device manufacturers and suppliers</strong></span></span></p>
	</li>
	<li>
	<p><span style="font-size:14px"><span style="font-family:Arial,Helvetica,sans-serif"><strong>Post-training audit tools and guidance provided</strong></span></span></p>
	</li>
</ul>
