Post-Market Surveillance
81 articles
Field Service Traceability for Software-Enabled Medical Devices
Build field service traceability for software-enabled devices with service records, software logs, audit trails, complaint links, QMSR, ISO 13485, and Part 11.
Preventive Maintenance and Calibration Intervals for Medical Devices
How to justify preventive maintenance and calibration intervals using risk-based methods, AEM programs, reliability data, ISO 13485, FDA QMSR, and Joint Commission expectations.
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.
PMCF Survey Design: Evidence Level, Sample Size, Endpoints, and Bias Controls
Design EU MDR PMCF surveys that Notified Bodies accept, with sample frames, CER endpoint mapping, acceptance criteria, statistics, bias controls, and adverse event capture.
SBOM-to-VEX Vulnerability Triage Workflow for Medical Device PSIRTs
PSIRT playbook for medical device SBOM-to-VEX triage, covering CVE intake, component matching, exploitability analysis, VEX rationale, severity scoring, CAPA, field action, and communications.
Coordinated Vulnerability Disclosure for Medical Device Cybersecurity
Practical guide to medical device CVD programs, including PSIRT setup, vulnerability intake, CVSS scoring, SBOM linkage, FDA Section 524B, EU expectations, and customer communication.
Medical Device Recall Trends 2024-2026: Statistics and Root Causes
Analyze 2024-2026 medical device recall trends, including Class I increases, device failure causes, software defects, FDA alerts, affected units, and risk mitigation.
PSUR Under EU MDR Article 86: 2026 Periodic Safety Update Report Guide
Prepare an EU MDR Article 86 PSUR with class-based frequency, MDCG 2022-21 structure, EUDAMED submission, PMS data, and benefit-risk analysis.
EU MDR SSCP Guide: Safety and Clinical Performance Summary for Devices
Learn how to prepare, validate, translate, and publish EU MDR SSCPs under Article 32, including MDCG 2019-9 Rev.1, lay summaries, NB review, and EUDAMED.
MENA Post-Market Surveillance & Vigilance: SFDA, EDE & Regional Requirements (2026)
Compare MENA post-market surveillance and vigilance rules for devices, including Saudi SFDA, UAE EDE, Turkey TITCK, Israel IRH, Egypt EDA, reporting timelines, PSURs, and shortage notices.
Field Safety Corrective Action (FSCA): EU MDR Vigilance Guide
Manage EU MDR Field Safety Corrective Actions, including FSCA triggers, 2/10/15-day reports, Field Safety Notices, EUDAMED, and FDA recall differences.
Medical Device Complaint Handling: FDA, ISO 13485 & EU MDR Requirements
Guide to complaint handling for medical devices under FDA QMSR, ISO 13485, and EU MDR, covering intake, reportability, CAPA links, records, and audits.
EUDAMED Day Zero Playbook: Role-Specific Actions Before May 28, 2026
Role-by-role playbook for the May 28, 2026 EUDAMED deadline, covering actor registration, UDI/device data, certificates, surveillance duties, and final readiness steps.
FDA Form 483 and Warning Letter Response Guide for Medical Devices
Guide to responding to FDA Form 483 observations and Warning Letters for medical devices, including 2025-2026 enforcement trends, top violations, response strategy, and draft guidance.
FDA Medical Device Recalls: Corrections, Removals, and Classification
Guide to FDA medical device recalls under 21 CFR 7, 806, and 810, including voluntary and mandatory recalls, Class I/II/III classification, reporting, strategy, and compliance.
FDA Medical Device Reporting: Adverse Event Rules Under 21 CFR Part 803
Guide to FDA Medical Device Reporting under 21 CFR Part 803, including reportable events, 30-day and 5-day deadlines, eMDR submissions, MAUDE, and enforcement risk.
EU MDR PMCF Guide: Plans, Studies, Reports, and Implementation
Guide to PMCF under EU MDR, including PMCF plans, study design, evaluation reports, PMS integration, clinical evaluation updates, and implementation.
FDA MAUDE Database: Search and Use 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.