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<a href="training_medical.html"><img src="images/arrow_back.gif" /> back to Training for the Medical Device Industry
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<h1>Software Development for Medical Device Manufacturers </h1>
<br/><br/>
<span class="bold">Newly updated in 2025 to help your organization prepare for new FDA QMSR + ISO 13485 <br>
<br>Compliance required Feb 2026 <br/> </span><br/>
The regulatory landscape for medical device software development is changing dramatically. Beginning in February 2026,
device manufacturers must comply with the new FDA Quality Management System Regulation (QMSR) which is based on the ISO 13485 Medical Device Quality Management System Standard. In addition, a recently adopted standard for security risk management (AAMI SW96) adds additional requirements for cybersecurity.
This course provides insight into these changes as well as requirements for safety risk management as defined in ISO-14971 Medical Device Risk Management and IEC-62304 Medical Device Software - Software Life Cycle Process. Also discussed is IEC-62366-1 Medical Devices - Application of Usability Engineering.
This course reflects both current FDA regulations as well as the new FDA QMSR + ISO-13485, ISO-14971, IEC-62304,IEC 62366-1 and AAMI SW96.
<br/><br/>
<img src="images/arrow.gif"/><a href="images/Syllabus_2025.pdf" target="_blank"> Click to view course syllabus </a>
<!--
<h2>Topics covered:</h2><br/>
<h2>Part 1 - Design and Development Processes</h2><br/>
The course begins with the Regulatory Roadmap that device manufacturers are expected to navigate. The Design and Development process outlined in both the FDA QSR and in the new QMSR (ISO 13485 Section 7.3) are discussed in detail along with corresponding requirements from IEC 62304 Medical Device Software Lifecycle Processes. Woven into the discussion of Design and Development are numerous examples of Best Practices.
<span class="bold">Introduction </span>
<ul class="indent">
<li>FDA's New Quality Management System (QMSR) </li>
<li>Regulatory Roadmap </li>
<li>FDA Guidance Documents and International Standards </li>
</ul><br/>
<span class="bold">Design and Development Planning </span>
<ul class="indent">
<li>Design and Development Inputs </li>
<li>Design and Development Outputs</li>
<li>Design and development Reviews </li>
<li>Design and Development Verification </li>
<li>Design and Development Validation </li>
<li>Design and Development Transfer </li>
<li>Design and Development Changes </li>
<li>Design and Development Files </li>
</ul><br/>
<span class="bold">Writing Requirements for Software </span>
<ul class="indent">
<li>Requirements Family Tree</li>
<li>Challenges Expressing Requirements</li>
<li>Techniques to Improve Requirements</li>
</ul><br/>
<span class="bold">Validation of Software Development Tools and tools used in Manufacturing and Quality Systems
</span>
<h2>Part 2 - Safety and Security Risk Management</h2><br/>
The similarities and differences between Safety Risk Management (ISO 14971) and Security Risk Management (AAMI SW 96) are discussed. Security Risk Management is based on the Risk Management framework defined in ISO 14971 but is focused on establishing a Secure Product Development Framework to minimize the risk of cybersecurity events. FDA and EU Guidance documents are discussed along with AAMI Principles for Medical Device Security – Risk Management TIR 57. Extensive references and examples of Best Practices are included.
<br/><br/>
<span class="bold">Safety Risk Management Process as defined by ISO-14971 </span>
<ul class="indent">
<li>Context for Safety Risk Management </li>
<li>Safety Risk Analysis </li>
<li>Safety Risk Evaluation </li>
<li>Safety Risk Control </li>
<li>Software-specific Issues </li>
<li>Risk Management Tools - Fault Tree Analysis </li>
<li>Production and Post-production Activities </li>
<li>Risk Documentation Repositories </li>
</ul><br/>
<span class="bold">Security Risk Management Process as defined by AAMI SW 96 and TIR57 </span>
<ul class="indent">
<li>Context for Security Risk Management </li>
<li>Security Risk Analysis </li>
<li>Security Risk Evaluation </li>
<li>Security Risk Control </li>
<li>Evaluation of Security Risk Acceptability </li>
<li>Security Risk Management Review </li>
<li>Production and Post-production Activities </li>
<li>Risk Documentation Repositories </li>
</ul><br/>
<br/><br/>
<h2>Tailoring</h2>
Courses and seminars can be tailored to meet your specific needs and all are based on the simple principle
that real learning occurs when people are actively involved.<br/><br/>
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