Regulatory
567 articles
MHRA Ambient Voice Technology 2026: When an AI Scribe Is a Medical Device in Great Britain
MHRA and NHS England 2026 guidance on ambient voice technology (AVT): 9-example medical device qualification tree, Class I vs IIa, DCB0129, and UKCA strategy.
MDCG 2026-5 UDI Assignment: Manufacturer vs Distributor Decision Tree
MDCG 2026-5 UDI assignment guide: 3-path decision tree for private-label distributor brands, MDR Article 16, Basic UDI-DI rules, and EUDAMED registration.
Medical Device Expanded Access: Emergency Use, Compassionate Use & Treatment IDE
Operational guide to US investigational device expanded access: emergency use, compassionate use IDE supplements, Treatment IDE (21 CFR 812.36), and IRB rules.
Medical Device Trial Master File (TMF) and ISF Guide: ISO 14155, FDA, and EU MDR
Complete guide to medical device TMF and ISF: ISO 14155:2026 Annex E essential documents, 21 CFR 812.140, EU MDR archiving, and device-unique artifacts.
IVDR Performance Study Requirements: Application vs Notification, Timelines, and Reporting
Comprehensive guide to IVDR Chapter VI performance studies: Article 58 application triggers, Article 70 PMPF notifications, Article 66 timelines, leftover samples, and safety reporting.
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.
Protocol Deviations in Medical Device Clinical Trials: FDA Guidance and EU Rules
Comprehensive guide to protocol deviations in medical device clinical trials: FDA draft guidance, 21 CFR 812, EU MDR Article 75, ISO 14155:2026, and BIMO metrics.
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.