MedDeviceGuide — IVD & Medical Device Knowledge Base
EUDAMED Actors by the Numbers: 48,071 Manufacturers, Importers, and ARs (2026)
A deep quantitative teardown of the EUDAMED Actor module. Analysis of role distribution, country concentration, non-EU manufacturer dependencies, and EU Authorised Representative capacity.
FDA De Novo Database Teardown: Grants by Year, Panel, and Pathway (1997-2025)
A deep quantitative teardown of the FDA De Novo database. Analysis of annual grant trends, review timelines, advisory panel distributions, and the strategic cost-benefit of the pathway.
Medical Device Classification Compared: FDA vs EU MDR vs UK vs IMDRF
A comparative guide to medical device risk classification across the US (FDA), EU (MDR), UK (MHRA), and IMDRF frameworks, featuring worked examples of classification divergence.
Coronary & Peripheral Stent Recalls: Boston Scientific, Abbott & Medtronic Teardown
A manufacturer-spanning deep dive into FDA stent recalls and MAUDE adverse event reports. Analyzes 131 recalls, common failure modes, and recent 2025-2026 high-acuity events.
ESU Recalls: ConMed, Stryker, Megadyne & Olympus Surgical-Fire and Burn Teardown
A manufacturer-spanning deep dive into FDA electrosurgical unit (ESU) recalls and MAUDE adverse event reports. Analyzes 640 recalls, surgical fire risks, and QMS implications.
External Defibrillator & AED Recalls: ZOLL, Stryker, Philips & Cardiac Science Teardown
A manufacturer-spanning teardown of automated external defibrillator (AED) and external defibrillator recalls and MAUDE events. Analyzes 373 recalls, common failure modes, and QMS implications.
EU MDR Notified Body Capacity and the 2026-2030 Certificate Expiry Cliff
Data-driven analysis of EU MDR/IVDR certificate expiry timelines, notified body capacity concentration, and manufacturer country exposure using EUDAMED and NANDO data.
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.