Standards & Testing
71 articles
Human Factors Testing for Medical Devices: FDA and IEC 62366 Guide
Plan human factors testing for devices with FDA guidance, IEC 62366-1, formative and summative studies, sample sizes, HF submission categories, and review-ready documentation.
IEC 60601-1 Medical Electrical Equipment Safety Guide 2026
Guide to IEC 60601-1 compliance for medical electrical equipment, covering basic safety, essential performance, collateral standards, EMC, FDA, EU MDR, testing, and Edition 4.
Medical Device Packaging Validation: Complete Guide to ISO 11607 Compliance (2026)
Validate medical device packaging to ISO 11607, including sterile barriers, material qualification, aging studies, distribution simulation, seal testing, and shelf-life claims.
India BIS Certification for Medical Devices: Process, Standards, Costs, CDSCO
Guide to BIS certification for medical devices in India, covering required standards, ISI marking, testing, Manakonline, CDSCO overlap, timelines, and costs.
ISO 10993-1:2025: What Changed, Why It Matters, and How to Prepare
Practical guide to ISO 10993-1:2025 changes, including risk-based biological evaluation, the new table framework, exposure duration updates, genotoxicity, and compliance steps.
ISO 13485 Internal Audit Guide: Checklist, Process, and Best Practices
Guide to ISO 13485 internal audits, including Clause 8.2.4 expectations, audit planning, checklists, auditor qualifications, nonconformities, CAPA linkage, and certification readiness.
Medical Device Shelf Life and Stability Testing Guide
Plan shelf life and stability testing for medical devices, including ASTM F1980 accelerated aging, real-time studies, sterile barrier testing, packaging validation, and expiration dating.
Medical Device Process Validation: IQ, OQ, PQ, and the Complete Implementation Guide
Implement medical device process validation with IQ, OQ, and PQ methods, FDA and GHTF expectations, statistical tools, master plans, and continued process verification.
IEC 62366 Usability Engineering for Medical Devices: Complete Guide
Apply IEC 62366 usability engineering to medical devices, including the usability file, formative and summative evaluations, use-related risk analysis, FDA guidance, and EU MDR expectations.
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.