Why FMEA Should Not Be Used for Medical Device Design
Why Medical Devices Need Usability Engineering
Understanding Software Items – The Rationale Behind Ambiguous Definitions
Quality Management Systems in Medical Device Regulation
Key Points of ISO 13485 Revision
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