Post-Market Surveillance
19 articles
GB PMSR/PSUR Dual-Report Architecture: How to Structure Post-Market Surveillance Reports for Devices Sold in Both EU and Great Britain
Step-by-step guide to building a dual PMSR/PSUR reporting architecture that satisfies both EU MDR/IVDR and Great Britain SI 2024/1368 requirements — data-period alignment, GB-specific content, MHRA standardized format, FSCA linkage, trend reporting, record retention, and responsible-owner mapping.
MDR Article 88 Trend Reporting: How to Set Statistical Thresholds, Detect Adverse Trends, and Build a Defensible Reporting Workflow
A practical guide to implementing MDR Article 88 trend reporting — covering denominator selection, expected frequency calculation, statistical significance testing, severity escalation, complaint coding, CAPA linkage, PSUR/PMSR integration, and the MDCG 2025 draft Q&A requirements.
PCCP Drift Monitoring Protocol for AI Imaging Devices: Dataset Shift Detection, Performance Thresholds, and Retraining Triggers
How to design and implement a drift monitoring protocol for AI-enabled imaging devices under FDA PCCP — dataset shift, scanner drift, demographic drift, performance thresholds, monitoring cadence, retraining triggers, labeling changes, and when FDA submission is still required.
PMCF Survey Design That Notified Bodies Actually Accept: Evidence Level, Sample Size, Endpoints, and Bias Controls
How to design a PMCF survey under EU MDR that Notified Bodies accept as Level 4 clinical evidence — sample frame construction, inclusion/exclusion criteria, endpoint mapping to CER claims, acceptance criteria, statistical power, bias controls, adverse event capture, and when surveys alone are insufficient.
SBOM-to-VEX Vulnerability Triage Workflow for Medical Devices: From CVE Intake to Field Action Decision
Operational playbook for medical device PSIRT teams — SBOM component matching, exploitability analysis, VEX justification authoring, PSIRT severity scoring, CAPA trigger thresholds, field safety corrective action decisions, and customer communication timing.
Coordinated Vulnerability Disclosure for Medical Devices: Building a Post-Market Cybersecurity Program
Practical guide for building a coordinated vulnerability disclosure (CVD) program for medical devices — covering PSIRT setup, vulnerability intake and triage, CVSS scoring, SBOM linkage, field safety notices, FDA Section 524B requirements, EU expectations, and customer communication templates.
Medical Device Recall Trends 2024–2026: Statistics, Root Causes, and What Manufacturers Must Do
Data-driven analysis of medical device recall trends through 2024–2026 — 1,059 recall events, Class I recalls at a 15-year high, device failure as the new #1 cause, ~440 million units affected (up 55%), software defect trends, FDA early alert pilot, and risk mitigation strategies for manufacturers.
PSUR Under EU MDR Article 86: Complete Periodic Safety Update Report Guide with 2026 EUDAMED Requirements
How to prepare, structure, and submit a compliant PSUR under MDR Article 86 — frequency by device class, MDCG 2022-21 template walkthrough, EUDAMED submission for Class III and implantables, benefit-risk analysis, PMS data integration, and the 2025 simplification proposal that may change reporting cadence.
EU MDR Summary of Safety and Clinical Performance (SSCP): Complete Guide for Class III and Implantable Devices
How to prepare, validate, and publish the Summary of Safety and Clinical Performance (SSCP) under EU MDR Article 32 — MDCG 2019-9 Rev.1 template walkthrough, HCP and layperson sections, readability testing, Notified Body validation process, translation requirements, EUDAMED upload timelines, and common NB findings in 2026.
MENA Post-Market Surveillance & Vigilance: SFDA, EDE & Regional Requirements (2026)
Complete guide to post-market surveillance and vigilance requirements for medical devices across MENA — SFDA MDS-REQ11 (2-day/10-day/30-day reporting, change notifications, 90-day renewal), UAE EDE biennial PSUR for high-risk devices, Turkey TITCK 6-month shortage notification, Israel IRH periodic post-marketing reports, and Egypt EDA vigilance obligations.
Field Safety Corrective Action (FSCA): EU MDR Vigilance Reporting Guide
A complete guide to Field Safety Corrective Actions under EU MDR — when an FSCA is required, reporting timelines (2/10/15 days), how to prepare a Field Safety Notice (FSN), competent authority notification, EUDAMED integration, and how FSCA differs from FDA recalls.
Medical Device Complaint Handling: FDA, ISO 13485 & EU MDR Requirements
A complete guide to medical device complaint handling — regulatory requirements under FDA 21 CFR 820 (QMSR), ISO 13485, and EU MDR, step-by-step process, MDR reportability decisions, CAPA integration, and documentation best practices.
EUDAMED Day Zero: The Role-Specific Action Playbook for Manufacturers, Authorized Representatives, Importers, and Distributors (Final 50 Days Before May 28, 2026)
Role-by-role action playbook for the May 28, 2026 EUDAMED mandatory deadline — covering actor registration, UDI/device registration, certificate uploads, and market surveillance obligations with a countdown checklist and member-state penalty matrix.
FDA Form 483 and Warning Letter Guide: How to Respond and Protect Your Medical Device Business
Learn how to respond to FDA Form 483 observations and Warning Letters for medical devices. Covers 2025-2026 enforcement statistics, top violations, response strategies, and the March 2026 draft guidance on 483 responses.
FDA Medical Device Recalls: Complete Guide to Corrections, Removals, and Recall Classification (21 CFR 7, 806, 810)
Comprehensive guide to FDA medical device recalls — voluntary vs mandatory recalls, Class I/II/III classification, corrections and removals under 21 CFR 806, reporting requirements, recall strategy, health hazard evaluation, and compliance best practices.
FDA Medical Device Reporting (MDR): Complete Guide to Adverse Event Reporting Under 21 CFR Part 803
Comprehensive guide to FDA Medical Device Reporting (MDR) — who must report, what events are reportable, 30-day and 5-day timelines, eMDR electronic submission, complaint handling integration, MAUDE database, and enforcement risks.
Post-Market Clinical Follow-Up (PMCF) Under EU MDR: Plans, Studies, and the Complete Implementation Guide
A comprehensive guide to PMCF under EU MDR — covering PMCF plan development, study design, evaluation reports, integration with PMS and clinical evaluation, and practical implementation strategies.
FDA MAUDE Database: The Complete Guide to Searching and Using Medical Device Adverse Event Reports
How to search, interpret, and use the FDA MAUDE database — report types, data fields, search techniques, limitations, and practical applications for regulatory professionals.
Post-Market Surveillance for Medical Devices: The Complete Guide
Everything you need to know about post-market surveillance (PMS) for medical devices — regulatory requirements under FDA and EU MDR/IVDR, PMS plan templates, PMCF studies, PSURs, vigilance reporting, and practical guidance for building a PMS system from scratch.