Medical Device & IVD Blog
France Medical Device Distributor Landscape & Market-Entry Selection (2026)
A data-driven analysis of the French medical device distributor landscape based on the SNITEM registry, detailing segment mix, focus areas, and selection strategies.
Germany Medical Device Distributor Landscape & Market-Entry Selection (2026)
A data-driven analysis of the German medical device distributor landscape based on the BVMed registry, detailing role types, product categories, and selection strategies.
Custom-Made Medical Devices Under EU MDR: Annex XIII and the FDA Exemption
A complete guide to custom-made medical devices under EU MDR Annex XIII. Learn about the manufacturer statement, MDCG 2021-3, and FDA CDE comparison.
EU MDR Clinical Investigation Pathway: Sponsor Obligations, EUDAMED, and Timelines
A complete guide to medical device clinical investigations under EU MDR Articles 62-82. Learn about sponsor obligations, EUDAMED submissions, and ISO 14155.
European Health Data Space (EHDS) Regulation: Guide for Medical Device Manufacturers
How Regulation (EU) 2025/327 applies to medical devices and IVDs. Learn about Article 27 software components, CE marking, 2027-2031 deadlines, and GDPR alignment.
Baxter FDA Device Footprint: 510(k), PMA, Recall & Manufacturing Analysis
A comprehensive data-driven regulatory profile of Baxter's FDA clearances, PMA approvals, safety recalls, and manufacturing hubs after the Hillrom acquisition.
Becton Dickinson (BD) FDA Device Footprint: 510(k), PMA, Recall & Manufacturing Analysis
A comprehensive data-driven regulatory profile of Becton Dickinson's FDA clearances, PMA approvals, safety recalls, and manufacturing hubs after the 2026 Waters spin-off.
FDA Ventilator Recalls: Class I Events, MAUDE Deaths & Root-Cause Analysis (2024–2026)
A data-driven analysis of FDA ventilator recalls, MAUDE database adverse events, root-cause categories, and major Class I events from Vyaire, Hamilton, Baxter, and Philips.
FDA 510(k) Predicate Best Practices: Recall History, Creep, and the 2026 QMSR Gate
A regulatory strategy guide analyzing the FDA's predicate-selection best practices, predicate-creep recall risk, and the 2026 QMSR parallel gate.
Hologic Global Footprint: Genius 3D Mammography, Genius AI, and IVD Market Access
An FDA regulatory and market access footprint dossier of Hologic, mapping Genius 3D Mammography PMA P080003, Genius AI clearances, and Panther diagnostics.
ResMed Global Regulatory Footprint: AirSense 11, Smart Comfort AI, and Market Access
An FDA regulatory and market access footprint dossier of ResMed, mapping AirSense 11 and Smart Comfort AI clearances, product codes, and market shares.
DexCom Global Regulatory Footprint: G7, Stelo, and Market Access
An FDA regulatory and manufacturing footprint dossier of DexCom, mapping G7 and Stelo OTC clearances, product codes QBJ and SAF, and market access.
Intuitive Surgical Global Regulatory Footprint: da Vinci & Ion
An FDA regulatory and commercial footprint dossier of Intuitive Surgical, mapping da Vinci and Ion clearances, product codes, and global market access.
MDCG 2021-5 Rev.1 EU REP Symbol Transition Guide
A regulatory guide to the MDCG 2021-5 Rev.1 EU REP symbol transition, mapping OJEU decisions, Swiss and UK representative rules, and QMS timelines.
Edwards Lifesciences Global Medical Device Registrations Dossier
A global registry dossier for Edwards Lifesciences, analyzing medical device registrations across US FDA, Canada MDALL, Australia ARTG, EU EUDAMED, and other major markets.
Johnson & Johnson MedTech Global Medical Device Registrations Dossier
A global registry dossier for Johnson & Johnson MedTech, analyzing medical device registrations across US FDA, Canada MDALL, Australia ARTG, EU EUDAMED, and other major markets.
Saudi Arabia SFDA Registered Devices Teardown & Channel Map
A database teardown of the 163,185 medical devices registered under Saudi Arabia's SFDA, detailing MDMA risk class splits, manufacturer concentration, and AR lock-in risks.
Algeria MIPH Medical Device Import Teardown: 327 Approved Importers
A quantitative teardown of Algeria's MIPH list of 327 approved medical device importers, analyzing the SARL-dominated legal mix and Decree 24/22 reforms.
BD (Becton, Dickinson) Global Medical Device Registrations Dossier
A global registry dossier for Becton, Dickinson and Company (BD), analyzing medical device registrations across 25 non-US markets and the integration of CareFusion and C.R. Bard.
GE HealthCare
A global registry dossier for GE HealthCare, analyzing medical device registrations across 24 non-US markets and regional representative structures.