Engineering Reliability: What CTOs Need to Know About Regulatory-Grade Physiological Monitoring Validation   CTOs in medical-device startups face an engineering challenge that extends far beyond hardware and firmware. The success of a physiological monitoring product—whether a pulse oximeter, blood pressure monitor, or wearable sensing platform—depends on rigorous clinical research studies capable of supporting FDA and CE mark submissions. The gap between early engineering va

Setting the Standard in Clinical Research   Medical device and wearable technology developers face increasing demands for...

For medical device innovators, the leap from prototype to regulatory submission is filled with risk. Even a well-engineered product can...