The Startup Dream vs Regulatory Reality Building a medical device startup is about speed, ingenuity, and solving real healthcare challenges. Early-stage founders work relentlessly to create working prototypes, validate preclinical …
In the early stages of medical device development, platform infrastructure decisions are often delayed in favor of speed and flexibility. But choosing a compliance-ready OS early—before clinical trials begin—can save …
In modern healthcare, FDA Cybersecurity Compliance for Medical Devices is not optional—it is a regulatory requirement. However, a widespread misconception persists: many organizations believe that only network-connected medical devices require …
