Medical Device Benefit-Risk Analysis: Process & Best Practices
Medical device benefit-risk analysis is a structured evaluation of whether the clinical benefits of a device outweigh its residual risks. It is mandated under ISO 14971:2019, FDA regulations, and EU MDR. Thus, it is critical for regulatory approval, patient safety,...
9-Step Guide to FDA Design and Development Planning
FDA design and development planning is a structured process mandated under 21 CFR Part 820 (Quality System Regulation). It serves as the mandated roadmap for controlling a medical device’s progression from initial concept to a validated product. It ensures...
US FDA SaMD Classification System: A Comprehensive Guide
The US FDA classifies Software as a Medical Device (SaMD) using a risk-based framework. It places software into four classes (I–IV). Class IV represents the highest risk (life-critical decisions). On the other hand, Class I represents the lowest (supportive,...