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182 articles
Device Label Translation: Reconciling Units, Symbols, and Released Versions
How medical device RA/QA teams reconcile units, ISO symbols, and released versions across translation cycles before artwork issuance under FDA QMSR 820.45 and EU MDR GSPR 23.
Incomplete Supplier Change Notices: A Device QA Triage Guide
When a supplier change notice omits affected lots, dates, or technical details, device QA must hold unverified product, issue an evidence request, and halt close-out until facts are verified.
EClinCloud EDC for Device Studies: Linking Versions, Deficiencies and Endpoints
Evaluate whether a configurable EDC study build can reconstruct device models, firmware versions, deficiencies, and endpoint records for FDA and EU MDR trials.
ISO 20417:2026 Guide: FDA Rec# 5-149, July 1 2029 DoC Window & ISO 15223-1
Operational guide to ISO 20417:2026: FDA Rec# 5-149 complete recognition, the July 1 2029 DoC transition window, ISO 15223-1, 21 CFR 801, and EU MDR GSPR 23.
DHTs as Endpoints in Device Investigations: Investigational Device vs Measurement Tool
FDA DHT clinical investigation guide: investigational device vs remote measurement tool under 21 CFR 812, fit-for-purpose V&V, and August 2026 DDM status.
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.