Global
186 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.
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.
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.
China Volume-Based Procurement (VBP) for Medical Devices: Price Cuts & Strategy
Guide to China's NHSA volume-based procurement (VBP) for medical devices: round history, price cuts, provincial alliances, and multinational strategy.
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.
MDSAP in 2026: Revised Audit Approach, TGA Migration, and Post-QMSR Value
A strategic evaluation of MDSAP in 2026: analyzing the February 2026 revised audit approach, the TGA mdsap.global migration, and a post-QMSR ROI decision framework.
How to Choose a Medical Device CRO: Selection & Due Diligence (2026)
Vendor-neutral guide to selecting a medical device CRO: ISO 14155:2026 and ICH E6(R3) compliance, RFP execution, FDA 483 due diligence, and cost models.
FCPA Compliance for Medical Device Manufacturers: 2025 Shifts and Case Record
A guide to US FCPA compliance for medical device manufacturers, covering the 2025 DOJ guidelines, historical cases, distributor red flags, and QMS controls.
Outcomes-Based & Value-Based Contracts for Medical Devices: Commercial Playbook
A comprehensive guide to structuring outcomes-based and value-based contracts for medical devices. Analyzes OIG safe harbors, Stark Law, metrics, and case studies.