COLLECTIVE INVITES BITS IN BIO
Bringing together the best of Tech & Biotech, it's time for another Meetup with Bits in Bio, with the exciting topic: "Agile in a regulated world - 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.
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?
WHAT TO EXPECT?
Agile in a Regulated World - "Move fast and don't kill anyone"
Agility and velocity are deeply valued in tech and software startups — but what happens when your product lands in a hospital? Four speakers from across the regulated software landscape share hard-won lessons on shipping fast while meeting compliance, quality, and patient safety demands.
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.
TIMINGS
- 6.30PM: Doors open
- 7PM: Welcome & Intro
- 7.10PM: Speaker Talks
- 8.50PM – 9.10PM: Q&A — plenty of room for discussion and critical questions
- 9.10PM: Drinks & networking
- 11PM: Doors close
COLLECTIVE INVITES BITS IN BIO
Bits in Bio is a global community that brings together people from tech and biotech industries, learn from one another, and combine the best practices of the tech world with the understanding of biology.
Beyond human health, biotechnology and biomanufacturing can help us reach our climate and energy goals, enhance food security and sustainability, secure our supply chains, and stimulate economic growth. With biology, digital technology and AI evolving at breakneck pace and reinforcing one another, we believe that we are on the eve of novel tools and methods to develop sustainable solutions to the world’s most pressing problems.
GUEST POLICY - Collective Members only
CANCELLATION - Can’t make it? You can cancel your ticket up to 4h for this event.
- App: My Account (profile pic) > My Events & Tickets > Event > Request Cancellation
- Portal: My Account > Tickets > Event > Cancel Ticket
NO-SHOW POLICY -No-shows = missed chance for someone else.
We’re introducing a €25 contribution to the Wintercircus Fund for members who register but don’t attend.
The fund supports broader access to networks like ours.
Collective Type of Events
Collective Original - Our own signature events, created by and for the Collective community. These gatherings bring all members together to connect, learn, and grow. Fully curated and organized by Collective.
Collective Invites - Events we co-create with partner communities. You’ll meet new people, discover fresh ideas, and tap into networks beyond Collective , while still enjoying our signature vibe. Think of it as Collective + friends.
Collective Choice - Handpicked recommendations for great external events hosted at Wintercircus. Not organized by us, but absolutely worth your time. We arrange your access (tickets or %) and make sure you can join in, because we know you’ll love it.
