MedDeviceGuide — IVD & Medical Device Knowledge Base
UAE EDE Medical Device Registration Guide (2026): Complete Process After MOHAP Transition
UAE medical device registration guide under EDE, covering classification, fees, LAR requirements, DHA/DOH differences, and the post-MOHAP transition process.
Biggest Medical Device M&A Deals of 2025-2026: Complete Tracker
Tracker of major medtech M&A deals in 2025 and 2026, including Abbott-Exact Sciences and Boston Scientific-Penumbra, with deal values, strategic rationale, and industry trends.
Cardiovascular Device M&A: Why CV Leads All Medtech Deal Flow
Data-driven analysis of cardiovascular medtech M&A, covering Stryker-Inari, Boston Scientific-Penumbra, Medtronic-CathWorks, PFA, structural heart innovation, and dealmaking trends in 2025-2026.
Chile ISP Medical Device Registration Guide: Classification, Process & 2026 Decree Changes
Register medical devices in Chile through ISP, including classification, GICONA submission, fees, timelines, documentation, and the 2026 decree expansion.
EU MDR/IVDR Simplification 2026: Proposed Changes, Timeline & What Manufacturers Must Know
Guide to the European Commission MDR and IVDR simplification proposal, including software Rule 11, certificate validity, sandboxes, fees, timelines, and manufacturer impact.
How the FTC Is Shaping Medical Device M&A in 2025-2026
How FTC enforcement is reshaping medtech M&A in 2025-2026, including Edwards/JenaValve, GTCR/Surmodics, HSR changes, and state mini-HSR laws.
Medical Device Company Valuation: Methods, Multiples & Due Diligence
Guide to medical device valuation in 2025-2026, including EBITDA and revenue multiples, pre-revenue methods, deal structures, CVRs, earn-outs, and diligence.
Medical Device Startup Funding Guide: What VCs Want in 2026
Guide to medical device startup funding in 2026, including typical raise sizes by stage, VC evaluation criteria, active subsectors, investor landscape, and fundraising positioning.
The Rise of Medtech Divestitures & Spinoffs (2025-2026): Why Giants Are Breaking Up
Analysis of 2025-2026 medtech divestitures and spinoffs, including BD-Waters, J&J DePuy Synthes, Siemens Healthineers, Medtronic MiniMed, and why large players are breaking up.
Medtech IPO & SPAC Outlook for 2026: Medline, MiniMed, and the Return of Public Markets
Review the 2026 medtech IPO and SPAC outlook, including Medline, Medtronic MiniMed, digital health listings, SPAC activity, public market conditions, and the pipeline.
Peru DIGEMID Medical Device Registration Guide: Classification, Process & Fees
Register medical devices in Peru through DIGEMID, covering risk classification, VUCE submission, documentation, holder duties, fees, timelines, and market access strategy.
Private Equity in Medical Devices: Strategies, Deals & Trends (2025-2026)
Analysis of private equity in medtech, including the Hologic take-private, buy-and-build platforms, CDMO acquisitions, Medline IPO exit, and dry powder deployment.
Surgical Robotics M&A & Funding: The Race Beyond da Vinci
Analysis of surgical robotics M&A funding in 2025-2026, covering Intuitive, CMR Surgical, Medtronic Hugo, J&J OTTAVA, Distalmotion, VC, and PE consolidation.
Field Safety Corrective Action (FSCA): EU MDR Vigilance Guide
Manage EU MDR Field Safety Corrective Actions, including FSCA triggers, 2/10/15-day reports, Field Safety Notices, EUDAMED, and FDA recall differences.
FMEA for Medical Devices: Design, Process & Use Risk Analysis Explained
Use FMEA for medical device risk analysis, including DFMEA, PFMEA, UFMEA, ISO 14971 links, RPN scoring, step-by-step execution, and common errors.
Medical Device Complaint Handling: FDA, ISO 13485 & EU MDR Requirements
Guide to complaint handling for medical devices under FDA QMSR, ISO 13485, and EU MDR, covering intake, reportability, CAPA links, records, and audits.
ASEAN Device Entry: Distributor Qualification and Test Report Reuse Matrix
Six-country ASEAN matrix covering distributor licenses, QMS and warehouse requirements, vigilance setup, and where FDA or NMPA test reports may reduce retesting.
Borderline Product Classification Across FDA, EU MDR, ANVISA, and COFEPRIS
How to classify hand sanitizer, mouthwash, personal lubricants, and data recorders as medical devices or non-devices across FDA, EU MDR, Brazil ANVISA, and Mexico COFEPRIS.
Brazil ANVISA Medical Device Cost Breakdown: Fees and Add-Ons (2026)
2026 Brazil ANVISA device cost guide with government fees by class, BGMP audit costs, MDSAP carve-outs, ANATEL and INMETRO add-ons, and Brazilian Registration Holder retainers.
CE + FDA Approval Strategy: Unlock 25+ Markets and Cut Time-to-Market
Learn how dual CE Mark and FDA 510(k)/PMA approval expands access across 25+ markets, speeds reliance registrations, and improves market-entry leverage.