Training: compliant software development for medical devices

Sunbird Medical Devices specializes in medical device software.  We specialize in medical device software development, consulting around medical device software development, and trainings. We are experts in IEC 62304, FDA regulations, MDR, as well as ISO 14971 and ISO 13485.

Sunbird Medical Devices

Join expert Wessel Kooyman for a hands-on training on IEC 62304, covering compliant software development for medical devices.

Silversquare Stéphanie

<h3>Why join this training?</h3> This two-hour training is designed for developers, CTOs, Product Owners, and Project Managers who need a practical understanding of IEC 62304 and how to apply it in real-world software development. Wessel is a Committee Expert in the redesign of IEC 62304, shaping the future of medical software compliance.This is a rare opportunity to learn directly from someone shaping the very standards your business depends on.Whether you're a startup building your first product or an established company refining your processes, this training provides the knowledge you need to integrate compliance into your software development without slowing down innovation.Please note that spots are limited to ensure a qualitative training. Save yours now!

<h3>What you will learn</h3> Through clear explanations, real-world examples, and a practical approach, you will:✅ Understand what IEC 62304 requires and how to apply it in software development. ✅ Learn how to integrate a Quality Management System (QMS) into your processes (ISO 13485). ✅ Get clarity on risk management (ISO 14971) and its impact on software development. ✅ Learn how to document development phases correctly to streamline compliance and audits. ✅ Gain insights into eQMS and ALM tools to improve development workflows. ✅ Pick Wessel’s brain and get expert answers to your specific questions.

<h3>Who should attend?</h3> This training is ideal for:<ol><li>Software Developers &amp; Engineers working in the medical device industry.</li><li>CTOs &amp; Product Owners ensuring compliance while leading development teams.</li><li>Project Managers overseeing medical software development.</li><li>Regulatory &amp; Quality Professionals who want to better understand how IEC 62304 impacts software teams.</li></ol>

<h3>About the Instructor</h3> Wessel Kooyman is a seasoned expert in medical device software development with over 20 years of experience in the field. Wessel is a Committee Expert in the redesign of IEC 62304, shaping the future of medical software compliance.He is currently CEO at <a href="https://www.sunbirdmedicaldevices.com/" title="https://www.sunbirdmedicaldevices.com/" target="_blank" data-msys-clicktrack="0" rel="nofollow noopener noreferrer">Sunbird Medical Devices</a>, advising companies on regulatory-compliant software development.He has worked with both start-ups, major medical device manufacturers and other large companies (such as IBA, Abbvie, Biogen) to align their software development with industry standards, ensuring smoother regulatory approvals and successful product launches.He possesses deep expertise in QMS integration, risk management, and regulatory documentation for medical devices.

Agenda

Introduction

Regulatory landscape

What is a medical device?

ISO 13485 - Quality Management System

Risk management for medical devices - ISO 14971

Requirements & Specifications

IEC 62304 - The standard for medical device software development

eQMS and ALM software tools

Impact on your software development

Q&A - Ask your most pressing questions

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Training: compliant software development for medical devices

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Training: compliant software development for medical devices

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