Medical Device & IVD Blog
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.
FDA TAP Pilot Program Guide: Total Product Life Cycle Advisory Strategy
Guide to FDA CDRH Total Product Life Cycle Advisory (TAP) Pilot Program, Breakthrough Device eligibility, 14-day advisor meetings, and CMS payor alignment.
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.
Commercial Insurance Coverage for Medical Devices: Payer Policy and Prior Auth
Guide to US commercial and private-payer coverage for medical devices — medical policy, prior authorization, ERISA self-funded plans, appeals, and the Medicare NCD/LCD benchmark.
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.