Risk Management
30 articles
FDA Human Factors Final Guidance 2026: Three Submission Categories and What Changed
Guide to FDA's final Human Factors guidance (effective August 1, 2026), covering Categories 1-3, Decision Point D flexibilities, and eSTAR submission rules.
How to Get FDA to Tell You Which Center Will Regulate Your Product: The Pre-RFD Playbook
A comprehensive regulatory guide to FDA's Pre-Request for Designation (Pre-RFD) process for borderline and combination products under the revised November 2025 guidance.
FDA Ventilator Recalls: Class I Events, MAUDE Deaths & Root-Cause Analysis (2024–2026)
A data-driven analysis of FDA ventilator recalls, MAUDE database adverse events, root-cause categories, and major Class I events from Vyaire, Hamilton, Baxter, and Philips.
FDA Product Code FDT: A Quantitative Audit of Duodenoscope Recalls and MAUDE Events
An empirical, data-driven safety audit of FDA product code FDT (duodenoscopes). Analyze 31 classified recalls and 3,985 adverse events from the MAUDE database.
ISO 14971 Risk-Control Traceability: How to Spot and Fix Audit Gaps
Prepare your Risk Management File for FDA or Notified Body audits. Learn to classify, locate, and remediate risk-control traceability gaps before your next QMS inspection.
ISO 19011:2026: What the Updated Audit Standard Means for Medical Device Manufacturers
ISO 19011:2026 embeds hybrid auditing, digital evidence management, and updated auditor competence across the audit lifecycle — what ISO 13485 and QMSR programs need to update.
Medical Device Cybersecurity Patch Management Guide (2026)
Plan regulated cybersecurity patch deployment for fielded devices under EU MDR, FDA Section 524B, and the Cyber Resilience Act, from triage to verified rollout.
Auto-Injector Critical-Task Matrix for Human Factors Validation
Guide to auto-injector critical-task matrices for human factors validation, including URRA inputs, dose confirmation, hold time, misfire recovery, training decay, and FDA evidence expectations.
EU AI Act and MDR Single Evidence Matrix for AI Medical Devices
Guide to building one evidence matrix for AI medical devices under EU MDR and the EU AI Act, mapping Annex II/III files, ISO 14971 risks, PMS/PMCF, cybersecurity, data governance, and QMS evidence.
FDA Cybersecurity Unresolved Anomalies Table for Premarket Submissions
Guide to building an FDA unresolved software anomalies table for cybersecurity submissions, including CVSS, exploitability, clinical impact, controls, SBOM links, VEX status, and labeling.
GB PMSR/PSUR Dual Reporting for EU and UK Medical Devices
Structure PMSR and PSUR reports for devices sold in the EU and Great Britain, covering data periods, MHRA format, GB content, FSCA links, and retention.
MDR Article 88 Trend Reporting: Statistical Thresholds and Workflow
How to set MDR Article 88 trend reporting thresholds, choose denominators, test significance, escalate severity, link CAPA, and align PMSR/PSUR outputs.
PCCP Drift Monitoring for AI Imaging Devices: Thresholds and Retraining Triggers
Build FDA PCCP drift monitoring protocols for AI imaging devices, including dataset shift, scanner drift, thresholds, cadence, retraining triggers, and submission boundaries.
FDA Cybersecurity Premarket Deficiencies: 12 Rejection Reasons
Guide to 12 common FDA cybersecurity premarket deficiencies in 2026, including SBOM, threat modeling, risk assessment, Section 524B, guidance alignment, and practical fixes.
Nanotechnology in Medical Devices: Regulatory and Risk Assessment Guide
Assess medical devices with nanomaterials, including EU MDR Rule 19, FDA guidance, ISO 10993-22, exposure frameworks, nanotoxicology, sterilization, labeling, and regulatory strategy.
Benefit-Risk Analysis for Medical Devices: FDA, EU MDR, and ISO 14971 Decision Framework
Guide to medical device benefit-risk analysis, covering ISO 14971 residual risk, EU MDR AFAP expectations, FDA benefit-risk factors for PMA, De Novo, and 510(k), examples, and documentation.
Fault Tree Analysis for Medical Device Risk Management: FTA vs FMEA
Guide to Fault Tree Analysis under ISO 14971, including FTA vs FMEA, AND/OR gates, probability calculations, examples, and when top-down risk analysis works best.
Hazard Analysis Methods for Medical Devices: FMEA, FTA, PHA, HAZOP
Compare hazard analysis methods for device risk management, including FMEA, FTA, PHA, HAZOP, and use-related analysis under ISO 14971, IEC 62366, FDA, and EU MDR.
ISO/TR 24971 for Medical Devices: Practical Guidance for Applying ISO 14971
Practical guide to ISO/TR 24971:2020 for applying ISO 14971, including hazard identification, risk analysis methods, benefit-risk decisions, and cybersecurity.
Risk Management File vs Risk Management Report: ISO 14971 Documentation Explained
Clear guide to ISO 14971 risk management files and reports, including required contents, traceability expectations, document structure, and audit findings.