European Union
305 articles
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.
Data Monitoring Committees (DMC/DSMB) in Medical Device Clinical Trials
Comprehensive guide to DMC and DSMB oversight in medical device clinical trials: FDA 2006 vs 2024 guidance, chartering, stopping rules, and operator learning curve management.
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.
OEM vs Independent Ultrasound Service Provider: A Due Diligence Decision Tool
A neutral due-diligence framework for HTM and procurement leaders to evaluate OEM vs independent ultrasound service routes across QMS evidence, software licensing, calibration, and acceptance testing.
Refurbished Ultrasound Parts Purchasing Controls & Receiving Acceptance
A risk-based purchasing and receiving-acceptance workflow for used, tested, repaired, and refurbished ultrasound parts, informed by ISO 13485 Clause 7.4.
Ultrasound Board and Probe Repair Quality Agreement: Depot Deliverables and Clause Set
A contract-stage deliverables schedule and clause set for independent ultrasound repair depots, using 21 CFR 820.35(b) fields as a record template where appropriate.
How to Verify an Ultrasound Repair or Parts Provider's ISO 13485 and QMS Claims
A desktop-verification guide to auditing ISO 13485 scope, accreditation status, IAF CertSearch records, and FDA registration claims for ultrasound service vendors.
Cold Chain & Temperature-Controlled Distribution for Medical Devices & IVDs
Guide to cold chain distribution for medical devices and IVDs under ISO 13485 clause 7.5.11, GDP frameworks, shipper qualification, and excursion disposition.
Why Medical Device Clinical Trials Stop Early: 6,155 Terminated Studies Analysis
Analysis of 6,155 terminated medical device trials on ClinicalTrials.gov: leading failure causes, enrollment bottlenecks, and trial survival playbooks.
EU MDR Article 22: Systems and Procedure Packs — Producer Obligations Guide
Complete guide to EU MDR Article 22 system and procedure pack producer obligations, the no-additional-CE-mark rule, Article 22(4) triggers, UDI, and the FDA convenience-kit comparison.
Master Protocols and Platform Trials for Medical Devices: The Adoption Gap
Analysis of master protocol, platform, basket, and umbrella trial adoption in medical devices — with ClinicalTrials.gov data showing near-zero device uptake and when the design pays off.
Teleflex Global Regulatory Dossier: Arrow, UroLift, FDA Data & 2025 Sale
Data-driven regulatory dossier of Teleflex (NYSE: TFX): ~440 FDA 510(k)s, multi-country registration counts, Arrow Class I recalls, and the 2025 $2.03B divestiture.
EU MDR Article 97 Derogations: Legacy Device Contingency Playbook
Comprehensive guide to EU MDR Article 97 derogations, including MDCG 2022-18, Addendum 1 restrictions, national competent authority processes, and contingency planning.
HEOR and the Global Value Dossier: Building Device Evidence That Wins Reimbursement
A guide to HEOR and Global Value Dossier strategy for medical devices. Dissects device-specific economic modeling and payer evidence requirements.