Getting started: Overcoming Initial Obstacles in Medical Device Software Development
This webinar will provide you the major challenges in software qualification and classification for different functionalities. We explore MDR for software-hardware combinations and how AI is handled under the AI Act.
In addition, we will share essential resources, key standards, and guidance documents crucial for getting your product to market, from design and development to clinical evidence and technical documentation.
Agenda
00:00 – Introduction
04:47Â –Â What will be covered in the different sessions
07:06Â – Qualification of MDSW
14:29 – Hardware + Software combination
19:48Â – Classification of MDSW
26:53Â – Standards and Guidance
32:33Â – AI Act + Cybersecurity
07:06Â – Qualification of MDSW
14:29 – Hardware + Software combination
19:48Â – Classification of MDSW
26:53Â – Standards and Guidance
32:33Â – AI Act + Cybersecurity
43:57Â – Q&A
Speakers
Caroline Aernouts
Senior Consultant RA MD
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.