Meetup #20 - The AI Act and the implications for SaMD

The AI Act is now a reality and we will have to deal with it going into effect in 2026. As one of the ISO 13485 requirements is to keep track of new regulations, you will have to study the impact of the AI Act on your company. To make it easier, we will discuss the main things in this meetup group.

We will discuss the AI Act in general, but also what (additional) things you'll need to do within your software medical device company.

Main speaker
Stephen Gilbert - Professor - Medical Device Regulatory Science

Panelists
Miguel Amador - Partner and Chief Innovation Officer @ Complear
Stephen Gilbert - Professor in Medical Device Regulatory Science
Dr. Spencer Todd - CEO & Co-Founder @ FormlyAI | ex-FDA

Sponsor
This edition is proudly sponsored by FormlyAI!

FormlyAI gives you a new way to get a CE mark for your medical device. Often medical device founders feel lost or even taken advantage of when trying to figure out how to get through the CE marking process. The Formly software offers a DIY way to create every process and all documentation you need for your CE mark. With the help of expert regulatory support included in our one time-fee, you will never feel lost along the way.

The Formly software provides a regulatory roadmap to your CE mark that you can use to track your progress. Our fine-tuned AI takes input from you to generate design controls, risk assessments, and other requirements you need to get you from zero to CE mark, all in one package. With us you can get to market faster than doing it yourself and more affordably than using traditional consultants.

Agenda
5 minutes - General Intro
5 minutes - Community & Regulatory updates
20 minutes - Breakout groups to mingle & make new connections
30 minutes - The AI Act by Stephen Gilber
20 minutes - Audience Q&A answered by our Panel (Stephen, Spencer, Miguel)

Recordings
Please be aware that we are recording this meetup to share the knowledge afterwards. Anyone in the recording will be asked to approve the videos before we post them. Previously recorded editions are here:

- #19 - US vs EU
- #17 - AI
- #16 - Internal and External Audits
- #15 - SOUP
- #14 - Usability Engineering
- #13 - How to start a QMS
- #11 - Post-Market Surveillance