From Requirements to Code: A unified Medical Device Software (MDSW) development cycle that covers all requirements
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.
Agenda
00:00 – Introduction
02:32 – What will be covered in the different sessions
03:40 – Design and Development
31:54 – Agile vs Waterfall Development
34:35 – AI Act & Cybersecurity
03:40 – Design and Development
31:54 – Agile vs Waterfall Development
34:35 – AI Act & Cybersecurity
42:06 – Q&A
Speaker
Pieter Smits
SaMD Expert & Project Manager
Expert knowledge in Medical Devices
Let’s get your medical device to market. We support you from concept to launch in the full lifecycle.