AI in Medical Devices: Understanding the Review Process and Common Gaps
Free webinar with BSI and GBA Key2Compliance As artificial intelligence becomes increasingly integrated into medical devices, manufacturers face new challenges in demonstrating regulatory compliance. Understanding how AI is assessed, what notified bodies look for, and where common gaps arise is important when preparing for regulatory assessment. Join GBA Key2Compliance and BSI for a free webinar where […]
Is your AI software a medical device? Questions every health tech startup should ask early
You have identified a problem in healthcare and built an AI solution that could help solve it. Perhaps it analyses patient information, highlights patterns or supports a healthcare professional’s decisions. As you move from prototype to product, one question deserves attention early: could your software be a medical device? For a software startup, the answer […]
Breakfast seminar – Right from the start, AI-based medical devices
April 14th, 08:00–10:30 at GoCo, Mölndal Curious about how to successfully develop and scale AI-based medical devices from the very beginning? Join us for a breakfast seminar where we bring together experts and peers to share insights, discuss real challenges, and explore practical approaches. With an incredible line-up of presenters, moderator, and panelists, and an […]
Fusion of AI and Medical Devices- A Free webinar presented by BSI and GBA Key2Compliance
We’re excited to partner with Notified Body BSI! Thomas Doerge from BSI, along with our GBA Key2Compliance experts Azadeh Hajipour and Stina Gustafsson, will lead discussions on the challenges of proper control and effectively managing changes within the MedTech sector. As medical device manufacturers, you’re at the cutting edge of technology, balancing innovation with compliance. […]