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

On demand

1h

Medical Devices

English

Watch here

Share

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.

Speaker

Pieter Smits

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.