Bits in Bio 26.01 :: Agile in a regulated world
Hello Bits in Bio Belgium! 👋
Time for another Meetup, with the exciting topic that's been on our minds for a couple of years now: "Agile in a Regulated World". Or, in slightly spicier terms: move fast and don't kill anyone.
During this event, we'll explore what it really takes to build and ship software fast when that software lives in a regulated environment. From notified bodies (ever heard of these?) and regulatory perspectives to day-to-day software delivery in medtech and embedded systems, this evening is about one central question: how do you move fast without cutting corners on compliance, quality, and patient safety?
We will also make sure to properly introduce the topic and frame the discussion well, so both tech and biotech people can plug into the conversation, even if this is not their daily terrain.
Big thanks to Wintercircus & Collective for hosting us again at this iconic location in Ghent. 🙏
You can make the difference by spreading the word. 📣 Our mission is to bring together the brightest minds in tech and biotech, so bring your peers and acquaintances from either world. As always, we carefully pick speakers with genuinely different perspectives, backgrounds, and lenses on the topic. Let the ideas collide, and find novel paths forward. Hope to see many of you again!
Agility and velocity are deeply valued in startups and software teams. But what happens when your software lands in a hospital, a pharmaceutical company, a clinical workflow, or a medical device context?
Key challenges:
How do teams keep shipping quickly in a highly regulated environment?
Where do software and AI regulatory submissions tend to break down?
How do regulatory frameworks shape day to-day product and engineering decisions?
What does agile development actually look like in medical device software?
Speaker Line-up
Speaker Line-up
Talk #1 - Michal Szymonik (QServe, previously at SGS and VITO) - The regulatory lens: where software and AI submissions break down, how regulators assess them in practice, and what teams need to get right early.
Talk #2 - Robert Stöhr (previously at In The Pocket) - The agile delivery lens: how teams building medical device software can stay fast and adaptive without giving up traceability, quality, and compliance.
Talk #3 - Maarten Bamelis (PointCaré, CTO) - The healthtech leadership lens: how PointCaré is applying agile practices today while building software for critical care.
Talk #4 - Jan Smolders (Comate, Head of Software) - The engineering execution lens: how Comate structures its software delivery so compliance is built into the work, not bolted on afterward.
Location:
On-site: Wintercircus, Ghent
Practicalities for the evening on Wednesday, April 29:
18:30: Doors open, drinks and networking
19:00: Welcome and intro
19:10: Speaker talks
20:50: Q&A and open discussion
21:10: Drinks and networking
22:00: Doors close