Risk Management
30 articles
SOUP IEC 62304 Compliance Guide for Medical Device Manufacturers
Guide to managing SOUP under IEC 62304, covering identification, risk assessment, safety classification, documentation, open-source controls, and post-market monitoring.
IEC 62133 Battery Safety for Medical Devices: Testing and Compliance
Meet IEC 62133 battery safety requirements for medical devices, including testing, FDA and EU MDR expectations, UN 38.3 transport, battery management, and risk controls.
EU MDR Classification Rules (Annex VIII): Complete Guide to All 22 Rules with 2026 Updates
Walk through all 22 EU MDR Annex VIII classification rules, including invasive, active, software, nanomaterial, and special rules with 2026 guidance.
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.