FDA Enforcement Discretion (2026) for Medical Software & Apps
“If your health app does anything medical, the FDA will want a mountain of documentation and a clearance before your first patient ever opens it.” That is what most founders hear when they start building medical software for the US market. And for many products, it is...
Is your software a medical device? Guide 2026
That a pacemaker should be a regulated medical device is obvious. However, with software, especially apps, the ambiguity is greater. Software must also be classified as a regulated medical device under the Medical Device Regulation (MDR) if it is used for specific...
IEC 62304: Software Safety Classes A, B, C – Guide
“Our software cannot hurt anyone. It is bound to be safety class A.” We hear this sentence regularly in initial conversations. Sometimes it is true. Often our honest assessment is a different one. Some background: Alongside the risk class under the MDR, there is a...
Cyber Resilience Act (CRA) for MDR Medical Devices: Implications
It is 2026 and everyone is talking about the Cyber Resilience Act (CRA). The Cyber Resilience Act is new and it is big. Digital products have to meet strict cyber security obligations: report vulnerabilities, deliver updates, and do so across the entire product...
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