AI in Medical Devices: Making It Work, and Proving It

AI is opening new possibilities across the medical device industry. The hard part isn't making it work — it's proving it works: safely, predictably, and in a way regulators can approve and patients can trust.

In this webinar, engineering leaders from Critical Software, IQ Inc., and Bausch + Lomb break down what actually changes when AI enters a medical device — the questions to ask before you commit, and where teams stall between working prototype and approved product. They also share how the right people, with the right knowledge, at the right time, turn AI ambition into devices that reach patients.

What you’ll take away

Proving an AI-enabled device is safe, predictable, and approvable isn't a problem any single team can solve alone. This panel breaks down the three questions that decide whether AI ambition becomes a device that reaches patients.

• When AI is the right call

  A clear view of when AI is, and isn't, the right choice for a safety-critical design.

• The technical questions

  What to validate: performance, data, failure modes — before development starts.

• The regulatory questions

  What regulators will expect you to have already answered.

Everything you need to know before you join.

Speakers

• Barbara Vankirk – CEO, IQ Inc. (a Critical Software Company)

• Birpal Sachdev – Director, Digital Systems R&D, Bausch + Lomb

• Gonçalo Almeida – Principal Engineer, Critical Software

Why It Matters

For medical device teams, AI decisions made early — or skipped — are the ones that stall approval later. Getting the "when" and "what to ask" right from the start is what separates a working prototype from a device patients can trust.