Standards & Testing
44 articles
Medical Device Process Validation: IQ, OQ, PQ, and the Complete Implementation Guide
A comprehensive guide to process validation for medical devices — covering IQ, OQ, PQ methodology, FDA and GHTF requirements, statistical tools, validation master plans, and continued process verification.
IEC 62366 Usability Engineering for Medical Devices: Complete Guide
The definitive guide to usability engineering for medical devices — IEC 62366-1:2015, FDA human factors guidance, usability engineering file, formative and summative evaluations, use-related risk analysis, and EU MDR usability requirements.
ISO 10993 Biocompatibility Testing for Medical Devices: The Complete Guide
A comprehensive guide to biological evaluation and biocompatibility testing under ISO 10993 — from categorization and test selection to chemical characterization and FDA expectations.
IEC 62304 Medical Device Software Lifecycle: The Complete Implementation Guide
How to implement IEC 62304 for medical device software development — safety classification, lifecycle processes, SOUP management, documentation requirements, and practical tips for agile teams.