MedDeviceGuide — IVD & Medical Device Knowledge Base
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.
Bayesian Statistics for Medical Device Clinical Trials: FDA Guidance & Approvals
Master FDA CDRH guidance for Bayesian device trials. Explore prior borrowing, adaptive designs, 47 PMA approval statistics, and the 2026 drug draft contrast.
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.
FDA Electronic Product Radiation Control (EPRC) for Medical Devices (21 CFR 1000-1050)
Guide to FDA Electronic Product Radiation Control (EPRC) under 21 CFR 1000-1050: 1002.1 matrix, Laser Notice 50/56, Form 2877, and Section 539 civil penalties.
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.
FDA Consent Decrees of Permanent Injunction for Medical Device Manufacturers (2026)
Comprehensive guide to FDA consent decrees of permanent injunction under FD&C Act Section 302, sign-or-sue letters, CGMP remediation, executive liability, case studies, and recovery strategies.
FDA Human Factors Final Guidance 2026: Three Submission Categories and What Changed
Guide to FDA's final Human Factors guidance (effective August 1, 2026), covering Categories 1-3, Decision Point D flexibilities, and eSTAR submission rules.
Australia Prescribed List: Device Reimbursement Tiers, Fees and Benefit Reform
Complete guide to the Australia Prescribed List (formerly Prostheses List), covering application tiers, HPA pathways, 2026-27 cost recovery fees, benefit reductions, and post-listing review.
FDA Medical Device User Fees FY 2027: MDUFA Rate Table and Budget Decisions
Complete guide to FDA medical device user fee rates for FY 2027 (MDUFA V), covering 510(k), De Novo, PMA, registration fees, small business waivers, and filing decisions.
FDA MRI Safety Labeling and GUDID Status: Data Analysis of 5.15M Device Records
Data analysis of 5.15 million FDA GUDID records evaluating MRI safety status distribution, ASTM F2503 labeling rules, implantable device coverage gaps, and 2023 guidance compliance.
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.
FDA Bioresearch Monitoring (BIMO) and 21 CFR Part 58 GLP Device Guide
Guide to FDA Bioresearch Monitoring (BIMO) and 21 CFR Part 58 GLP for device sponsors, covering compliance manuals, NAI/VAI/OAI, and PMA pre-approval audits.
Medicare IPPS and MS-DRGs for Medical Devices: Inpatient Payment Guide
Guide to Medicare IPPS and MS-DRGs for medical devices, covering inpatient payment calculation, NTAP add-on payments, and the FY2027 Breakthrough overhaul.
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.