Differences in Approach Between JIS Standards and FDA Guidance: Current State of International Harmonization
Learning from Smartphone Usability: Principles for Medical Device Design
Boeing and Airbus Design Philosophy: Understanding the Fundamental Approaches to Aircraft Development
Why Severity Takes Precedence Over Frequency: A Practical Approach to Risk Control in Medical Devices
Distinguishing Between Quantitative and Qualitative Assessment
Why Objective Evidence Matters: Performance Evaluation and Regulatory Requirements in Medical Devices
Medical Devices Where Training Becomes an Approval Requirement
Why Should We Focus on Differences from Predicated Devices in Medical Device Design?