Medical Device Software Development in 2026: Regulatory and Technical Overview
A comprehensive guide to medical device software development (SaMD) in 2026. We cover IEC 62304, FDA regulations, and the technical challenges of AI integration.
A comprehensive guide to medical device software development (SaMD) in 2026. We cover IEC 62304, FDA regulations, and the technical challenges of AI integration.
If you’re a business owner planning a “health app,” here’s the moment things get expensive: You write one sentence that sounds like a medical claim. “Detects arrhythmia.” “Helps diagnose.” “Guides therapy.” “Predicts deterioration.” Now you’re not building an app. You’re building a regulated medical device—and the rules will shape your roadmap more than your feature […]
Most fitness apps don’t lose because they lack features. They lose because they mistake “workouts” for the product. The real product is habit: the tiny loop that gets someone to show up on a random Tuesday when motivation is dead and the sofa is winning. In 2026, “another workout library” is the fastest way to […]
If you’ve never built an EHR, here’s the trap you’re about to step in: You’ll spend 6 months building “features” and then get blocked by one sentence from compliance: “Cool. Where’s your audit trail, risk analysis, and access control model?” And suddenly your “MVP” becomes a rewrite. Let’s be blunt: EHR development in 2026 is […]
Picture this: a patient is trying to work through a fear of crowded spaces. In the real world, “exposure” means logistics, uncertainty, and a lot of variables you can’t control: Now swap that with VR: the same crowded setting, on-demand, repeatable, adjustable, and safe to pause at any second. That’s the core of Virtual Reality […]
Let me guess how this started. Someone on your team said: “We need an app.” Someone else said: “We already have a website. Can’t we just turn it into an app?” Yes, you can. But the real business question isn’t “can we?” It’s: Will an app improve retention, revenue, or efficiency enough to justify the […]