Risk Management
27 articles
EU MDR GSPR Annex I: General Safety and Performance Requirements Guide
Guide to demonstrating compliance with EU MDR Annex I GSPR, including all 23 requirements, evidence mapping, standards, cybersecurity, AI, and NB review tips.
IEC 60601-1-2 EMC Testing for Medical Devices
Meet IEC 60601-1-2 EMC requirements for medical electrical equipment, including emissions, immunity, Edition 4.1, risk management, test plans, environments, and submissions.
ISO 14155:2026 Clinical Investigation of Medical Devices: GCP Guide
Guide to ISO 14155:2026 for medical device clinical investigations, covering GCP expectations, risk management, committees, estimands, sponsor duties, adverse events, and post-market studies.
Root Cause Analysis for Medical Devices: RCA Methods, Tools, and CAPA Integration
Guide to medical device root cause analysis, covering 5 Whys, fishbone diagrams, fault tree analysis, Pareto charts, CAPA links, and FDA 483 risks.
FMEA for Medical Devices: Design, Process & Use Risk Analysis Explained
Use FMEA for medical device risk analysis, including DFMEA, PFMEA, UFMEA, ISO 14971 links, RPN scoring, step-by-step execution, and common errors.
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.
ISO 14971 Risk Management for Medical Devices: The Complete Guide
A comprehensive guide to implementing ISO 14971 risk management for medical devices — from hazard identification through risk control to post-production monitoring.