European Union
305 articles
EDC Validation for Medical Device Trials: Part 11 and Data Integrity
Guide to validating EDC systems for medical device clinical trials, covering 21 CFR Part 11, audit trails, GAMP 5, IQ/OQ/PQ, ALCOA+ data integrity, sponsor duties, and FDA inspection risks.
eIFU for Medical Devices: EU MDR, FDA Rules, QR Codes, and Paper IFUs
Guide to electronic IFU rules for medical devices, covering EU Regulation 2025/1234, FDA 21 CFR Part 801, website access, QR codes, paper fallback, IVDR, SaMD, and validation.
EU Medical Device Registration Cost 2026: EC REP Pricing Models
Buyer-side breakdown of EU medical device registration costs in 2026, comparing EC REP hourly, registration-plus-annual, and flat-fee pricing with three-year scenarios.
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.
EU MDR Literature Search Protocol for Clinical Evaluation and CER Evidence
Build an EU MDR literature search protocol for clinical evaluation, covering Article 61, Annex XIV, MEDDEV methodology, PICO, databases, appraisal, PRISMA, and Notified Body expectations.
Patient-Reported Outcomes in Device Trials: PRO Validation and FDA/EU Expectations
Use PRO instruments in medical device trials with fit-for-purpose validation, endpoint planning, FDA CDRH expectations, EU MDR evidence, and submission strategy.
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.
SaMD vs SiMD vs Embedded Software: Classification, Documentation, and Regulatory Strategy
Guide to classifying SaMD, SiMD, and embedded medical device software, with IMDRF definitions, IEC 62304 risk classes, FDA and EU MDR pathways, and documentation strategy.
Sample Size Calculation for Medical Device Clinical Investigations: Methods and Examples
Practical guide to sample size justification for device clinical investigations, covering ISO 14155, EU MDR Annex XV, FDA IDE expectations, common study designs, and worked examples.
State of the Art Review for Medical Devices: SOTA and CER Comparator Guide
Build a defensible SOTA review for EU MDR clinical evaluation, with comparator selection, benchmark devices, outcome parameters, MDCG evidence hierarchy, and CER examples.
Statistical Analysis Plan for Medical Device Trials: SAP Endpoints and Estimands
Develop a medical device SAP covering endpoints, estimands, analysis populations, missing data, sensitivity analyses, multiplicity, timing, and FDA/EU MDR expectations.
User Needs vs Design Inputs: Translating VOC into Medical Device Requirements
Learn how to translate VOC and user needs into verifiable design inputs with FDA QMSR, ISO 13485, traceability examples and audit-ready documentation.
GDPR Compliance for Medical Device and IVD Companies in 2026
Practical GDPR guide for device and IVD manufacturers, covering health data, DPIAs, DPO duties, lawful bases, transfers, EU MDR, IVDR, and AI Act overlap.
Medical Device Product Liability and Insurance: A Complete Guide for Manufacturers
Guide to medical device product liability and insurance, including strict liability, negligence, coverage types, EU 2024/2853 changes, recalls, and risk controls.
Medical Device Environmental Compliance: RoHS, REACH, WEEE Guide
Guide to medical device environmental compliance covering EU RoHS restricted substances, REACH SVHC and SCIP duties, WEEE producer obligations, global RoHS rules, and 2026 strategy.
Cloud-Based Medical Devices & SaaS: Regulatory Compliance Guide (FDA, EU MDR 2026)
Guide to FDA and EU MDR regulation of cloud-based medical devices and SaaS health platforms, covering SaMD, SiMD, IEC 62304, cybersecurity, CSA, CRA, and validation.
Mobile Medical Applications: FDA & EU MDR Regulatory Guide (2026)
Classify mobile medical apps under FDA and EU MDR rules, including device software functions, wellness exclusions, CDS updates, Rule 11, cybersecurity, privacy, app stores, and 2026 strategy.
Endotoxin and Pyrogen Testing for Medical Devices: BET Guide
Guide to medical device endotoxin and pyrogen testing, including BET methods, rFC alternatives, ISO 11737-3, USP <85>/<161>, FDA guidance, and device limits.