This training is both online and in-person, we have a space that can safely host 8 people. In addition to that, you can attend by Zoom.

In this 2 hour training session, we cover all aspects of medical device software development, including:

- What is ISO 13485, CE marking and FDA approval

- Levels and types of devices

- Am i a medical device?

- QMS'es - what is the purpose

- Software development under IEC 62304

- ALM and QMS automation

At the end of this session there will be a Q&A.

By attending this event, you agree to being recorded for the Zoom session.

This training is hosted by Wessel Kooyman, a developer, CTO, CEO and expert on medical device development.