From Requirements to Code: a unified MDSW development cycle that covers all requirements

Struggling with the complexities of Medical Device Software (MDSW) development? Need clarity on complying with standards like IEC 62304, IEC 82304, IEC 62366, and ensuring robust cybersecurity?

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1h

Medical Devices

English

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Description

This webinar will explore the specific requirements for various safety classifications and provide valuable insights into what Notified Bodies (NBs) and the FDA expect from your development process.

Key topics will include the full development cycle, cybersecurity essentials, usability engineering, AI integration, and effective strategies for aligning agile methodologies with the strict release flows required for MDSW.

Gain a deeper understanding and streamline your MDSW development process today!

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What you'll learn

• IEC 62304 safety classifications
• Integrate cybersecurity requirements
• Impact of the AI act on SaMD development
• Usability engineering in the development cycle
• Agile development frameworks
• Expectations of Notified Bodies and the FDA

Speaker

Join us as our expert speaker shares valuable insights and practical knowledge drawn from extensive industry experience.

Don’t miss the opportunity to learn and engage with professionals in the field.

Pieter Smits

SaMD expert & project manager

Pieter is a seasoned SaMD/MDSW expert with extensive experience in EU and US regulations and standards, especially in AI and cybersecurity regulatory requirements. His expertise covers compliance with regulations like MDR/IVDR and FDA legislation, alongside standards such as ISO 13485, IEC 62304, IEC 82304, ISO 62366, ISO 81001, and ISO 14971.

In addition to his technical expertise, Pieter brings valuable project management experience in the pharmaceutical and medical device industries, helping organizations solve complex problems and implement effective solutions to achieve their goals.

Pieter’s Mission: To prove that compliance and innovation can go hand in hand, while staying at the forefront of the evolving landscape of SaMD/MDSW legislation and standards.

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