<h3><span style="font-size:22px"><span style="font-family:Arial,Helvetica,sans-serif"><strong>What is ISO 13485?</strong></span></span></h3>

<p><span style="font-size:14px"><span style="font-family:Arial,Helvetica,sans-serif"><strong>ISO 13485:2016 is published by the International Organization for Standardization (ISO) and focuses on quality management systems in the lifecycle of medical devices, including:</strong></span></span></p>

<ul>
	<li>
	<p><span style="font-size:14px"><span style="font-family:Arial,Helvetica,sans-serif"><strong>Design and development</strong></span></span></p>
	</li>
	<li>
	<p><span style="font-size:14px"><span style="font-family:Arial,Helvetica,sans-serif"><strong>Production and manufacturing</strong></span></span></p>
	</li>
	<li>
	<p><span style="font-size:14px"><span style="font-family:Arial,Helvetica,sans-serif"><strong>Installation and servicing</strong></span></span></p>
	</li>
	<li>
	<p><span style="font-size:14px"><span style="font-family:Arial,Helvetica,sans-serif"><strong>Storage and distribution</strong></span></span></p>
	</li>
</ul>

<p><span style="font-size:14px"><span style="font-family:Arial,Helvetica,sans-serif"><strong>It is applicable to all organizations involved in one or more stages of the medical device lifecycle.</strong></span></span></p>

<h3><span style="font-size:22px"><span style="font-family:Arial,Helvetica,sans-serif"><strong>Who Needs ISO 13485 Certification?</strong></span></span></h3>

<p><span style="font-size:14px"><span style="font-family:Arial,Helvetica,sans-serif"><strong>This certification is ideal for:</strong></span></span></p>

<ul>
	<li>
	<p><span style="font-size:14px"><span style="font-family:Arial,Helvetica,sans-serif"><strong>Medical device manufacturers</strong></span></span></p>
	</li>
	<li>
	<p><span style="font-size:14px"><span style="font-family:Arial,Helvetica,sans-serif"><strong>Suppliers and vendors of components/materials</strong></span></span></p>
	</li>
	<li>
	<p><span style="font-size:14px"><span style="font-family:Arial,Helvetica,sans-serif"><strong>Contract manufacturers and sterilization providers</strong></span></span></p>
	</li>
	<li>
	<p><span style="font-size:14px"><span style="font-family:Arial,Helvetica,sans-serif"><strong>Distributors and importers</strong></span></span></p>
	</li>
	<li>
	<p><span style="font-size:14px"><span style="font-family:Arial,Helvetica,sans-serif"><strong>Organizations involved in technical support and installation</strong></span></span></p>
	</li>
</ul>

<h3><span style="font-size:22px"><span style="font-family:Arial,Helvetica,sans-serif"><strong>Key Objectives of ISO 13485</strong></span></span></h3>

<ul>
	<li>
	<p><span style="font-size:14px"><span style="font-family:Arial,Helvetica,sans-serif"><strong>Ensure compliance with global regulatory standards</strong></span></span></p>
	</li>
	<li>
	<p><span style="font-size:14px"><span style="font-family:Arial,Helvetica,sans-serif"><strong>Maintain product quality and safety</strong></span></span></p>
	</li>
	<li>
	<p><span style="font-size:14px"><span style="font-family:Arial,Helvetica,sans-serif"><strong>Improve customer satisfaction</strong></span></span></p>
	</li>
	<li>
	<p><span style="font-size:14px"><span style="font-family:Arial,Helvetica,sans-serif"><strong>Enhance risk management across operations</strong></span></span></p>
	</li>
	<li>
	<p><span style="font-size:14px"><span style="font-family:Arial,Helvetica,sans-serif"><strong>Facilitate market access and certification (like CE marking)</strong></span></span></p>
	</li>
</ul>

<h3><span style="font-size:22px"><span style="font-family:Arial,Helvetica,sans-serif"><strong>Benefits of ISO 13485 Certification</strong></span></span></h3>

<p><span style="font-size:14px"><span style="font-family:Arial,Helvetica,sans-serif"><strong>&nbsp;Regulatory Compliance<br />
Aligns your processes with global regulations (e.g., EU MDR, US FDA).</strong></span></span></p>

<p><span style="font-size:14px"><span style="font-family:Arial,Helvetica,sans-serif"><strong>Improved Product Quality &amp; Safety<br />
Reduces risks and enhances the reliability of medical devices.</strong></span></span></p>

<p><span style="font-size:14px"><span style="font-family:Arial,Helvetica,sans-serif"><strong>Global Market Access<br />
Essential for selling in international markets, including Europe and North America.</strong></span></span></p>

<p><span style="font-size:14px"><span style="font-family:Arial,Helvetica,sans-serif"><strong>Operational Consistency<br />
Standardizes your procedures, reducing errors and defects.</strong></span></span></p>

<p><span style="font-size:14px"><span style="font-family:Arial,Helvetica,sans-serif"><strong>Risk-Based Approach<br />
Implements proactive risk management in design and production.</strong></span></span></p>

<p><span style="font-size:14px"><span style="font-family:Arial,Helvetica,sans-serif"><strong>&nbsp;Compatibility with Other Standards<br />
Can be integrated with ISO 9001, ISO 14001, and ISO 14971 (risk management).</strong></span></span></p>
