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197 articles
IEC 62353 Recurrent Testing After Repair: OEM IFU Duties vs IEC 60601-1 & NFPA 99
IEC 62353 in-service electrical safety testing: manufacturer IFU duties, IEC 60601-1 type test differences, CMS S&C 14-07 major repair rules, and NFPA 99.
ISO 80369 Small-Bore Connector Conversion: 510(k), FDA Windows & Particular Parts
Manufacturer ISO 80369 conversion guide: route-specific particular parts, FDA recognition transition windows through Dec 17, 2028, and 510(k) change forks.
ClinicalTrials.gov Registration and Results Reporting for Medical Device Trials
Comprehensive guide to medical device clinical trial registration and results reporting: 42 CFR Part 11 ADCT criteria, 21-day clocks, Form FDA 3674, 2026 CMP updates, and EU MDR Article 77.
Informed Consent for Medical Device Clinical Trials: 21 CFR 50, EFIC & EU MDR Article 63
Complete guide to informed consent in medical device clinical trials: 21 CFR Part 50 & Part 812, 50.22 minimal-risk waiver, 50.24 EFIC, and EU MDR Article 63.
Safety Reporting in Medical Device Clinical Trials: US IDE, EU MDR & ISO 14155
Complete guide to safety reporting in medical device clinical trials: 21 CFR 812.150 UADE clocks, EU MDR Article 80, MDCG 2020-10/1 Rev.1, and ISO 14155 GCP rules.
Risk-Based Monitoring for Medical Device Clinical Trials: FDA, EU MDR & ISO 14155 Guide
Comprehensive guide to risk-based monitoring (RBM) in medical device clinical trials: 21 CFR 812.40, FDA 2023 Q&A, EU MDR Annex XV, ISO 14155:2026, and BIMO audit evidence.
Sham Controls in Medical Device Trials: Design, Ethics, and FDA/EU Expectations
Comprehensive guide to sham controls in medical device clinical trials: 21 CFR 860.7, EU MDR Article 62, Helsinki ethics, blinding protocols, and alternatives.
Imaging Core Labs for Medical Device Clinical Trials: FDA Expectations and Setup Guide
Comprehensive guide to imaging core labs in medical device trials: FDA expectations, charter anatomy, reader reproducibility (kappa/ICC), and vendor audit.
Enrichment Strategies for Medical Device Clinical Trials: Patient Selection Guide
Master enrichment strategies in medical device clinical trials: compare prognostic vs predictive designs, evaluate device-unique gates, and balance FDA DAPs.
Clinical Events Committees (CEC) and Endpoint Adjudication in Medical Device Trials
Guide to CEC endpoint adjudication in device trials: when it's required, CEC vs DMC vs core lab, charter anatomy, independence rules, and cost.
External and Historical Control Arms in Medical Device Clinical Trials
Guide to external and historical control arms in medical device trials: FDA acceptance, OPC vs external controls, MAIC, and exchangeability rules.
Multiplicity and Multiple-Endpoint Testing in Medical Device Clinical Trials
Master multiplicity control in device trials: learn FDA 2022 & CDRH rules, co-primary & composite exemptions, Holm/gatekeeping methods, and IVD endpoint strategies.
Pure Global AI: A Practical Workflow Guide for Medical Device Regulatory Teams
A vendor-neutral guide to Pure Global AI's regulatory databases, device and predicate agents, and evidence-first workpapers for risk, eSTAR, CAPA, QMSR, labeling, and post-market review.
Superiority and Equivalence Clinical Trial Designs for Medical Devices
Master superiority and equivalence trial designs for medical devices: navigate TOST mechanics, OPC benchmark derivation, CLSI EP09 agreement, and FDA standards.
Adaptive Designs for Medical Device Clinical Studies: FDA Guidance, Types, and ICH E20
Master adaptive clinical trial designs for medical devices: navigate FDA CDRH guidance, evaluate 10+ adaptation types, preserve trial integrity, and align with ICH E20.
Non-Inferiority Clinical Trials for Medical Devices: Margin & Design Guide
Master non-inferiority clinical trials for medical devices: set M1 and M2 margins, protect against learning curves and biocreep, compare FDA and EU MDR, and analyze pivotal trial cases.
Should You Trust AI in Regulatory Work? A Vendor-Neutral Checklist After DJ Fang's Pilot
A vendor-neutral operational audit for medtech RA and quality teams evaluating AI workflow tools, covering CSV, source provenance, master dossier reuse, and reliance.
Disposable Circumcision Device Supplier Qualification: CE, ISO 13485 & MOQ
A purchasing-control guide for qualifying disposable circumcision device suppliers: CE marking, ISO 13485 scope, size mix, MOQ landed cost, and sample acceptance.
Medical Cyanoacrylate Tissue Adhesive Sourcing & Regulatory Guide
A technical sourcing guide for medical cyanoacrylate tissue adhesives: intended use classification, 2-octyl vs n-butyl chemistry, ISO 10993, and lot release.
NPWT Supplier Qualification: Pump–Dressing Compatibility, Alarms, QMS and Total Cost
A technical due-diligence guide for qualifying NPWT systems: pump-dressing compatibility, alarm performance, regulatory scope, and total cost of therapy.