MedDeviceGuide — IVD & Medical Device Knowledge Base
Medical Device Company Valuation: Methods, Multiples & Due Diligence
A comprehensive guide to medical device company valuation in 2025-2026 — covering EBITDA and revenue multiples by subsector, valuation methods for pre-revenue and commercial-stage companies, deal structures including earn-outs and CVRs, and the due diligence process.
Medical Device Startup Funding Guide: What VCs Want in 2026
A practical guide to raising venture capital for medical device startups in 2026 — covering typical raise amounts by stage, what investors evaluate, hot subsectors, the VC ecosystem, and how to position for a successful fundraise.
The Rise of Medtech Divestitures & Spinoffs (2025-2026): Why Giants Are Breaking Up
A comprehensive analysis of the wave of medtech divestitures and spinoffs reshaping the industry — from BD's $17.5B Waters deal to J&J's DePuy Synthes separation, Siemens Healthineers deconsolidation, and Medtronic's MiniMed IPO.
Medtech IPO & SPAC Outlook for 2026: Medline, MiniMed, and the Return of Public Markets
A comprehensive analysis of the medtech and healthcare IPO landscape in 2026 — from Medline's record $6.3B listing and Medtronic's MiniMed Diabetes spinoff IPO to digital health debuts, SPAC resurgence, and what's in the pipeline.
Peru DIGEMID Medical Device Registration Guide: Classification, Process & Fees
A complete guide to registering medical devices in Peru through DIGEMID. Covers the four-class risk system under Law 29459, VUCE electronic submission, documentation requirements by class, Peru Registration Holder obligations, fees, timelines, and practical strategies for faster market access.
Private Equity in Medical Devices: Strategies, Deals & Trends (2025-2026)
A deep dive into private equity's growing role in medtech — from Blackstone and TPG's landmark $18.3B Hologic take-private to buy-and-build platforms, CDMO acquisitions, the record Medline IPO exit, and PE dry powder deployment strategies.
Surgical Robotics M&A & Funding: The Race Beyond da Vinci
A comprehensive analysis of the surgical robotics M&A and funding landscape in 2025-2026 — from Intuitive's dominance to the rise of challengers like CMR Surgical, Medtronic Hugo, J&J OTTAVA, and Distalmotion, plus the shift from VC-backed pioneers to PE-led consolidation.
Field Safety Corrective Action (FSCA): EU MDR Vigilance Reporting Guide
A complete guide to Field Safety Corrective Actions under EU MDR — when an FSCA is required, reporting timelines (2/10/15 days), how to prepare a Field Safety Notice (FSN), competent authority notification, EUDAMED integration, and how FSCA differs from FDA recalls.
FMEA for Medical Devices: Design, Process & Use Risk Analysis Explained
A complete guide to Failure Mode and Effects Analysis (FMEA) for medical devices — DFMEA, PFMEA, UFMEA, how FMEA relates to ISO 14971, step-by-step instructions, RPN scoring, and common mistakes to avoid.
Medical Device Complaint Handling: FDA, ISO 13485 & EU MDR Requirements
A complete guide to medical device complaint handling — regulatory requirements under FDA 21 CFR 820 (QMSR), ISO 13485, and EU MDR, step-by-step process, MDR reportability decisions, CAPA integration, and documentation best practices.
ASEAN Medical Device Entry: The 6-Country Matrix for Distributor Qualifications and FDA/NMPA Test Report Reuse
A reference matrix answering two questions not covered in any existing ASEAN guide: what specific licenses, QMS certifications, warehouse infrastructure, and pharmacovigilance setup must your distributor hold in each of the 6 major ASEAN markets, and which countries accept FDA or NMPA test reports without full retest.
Is It a Medical Device? Borderline Product Classification for Hand Sanitizer, Mouthwash, Personal Lubricants & Data Recorders Across FDA, EU MDR, Brazil ANVISA and Mexico COFEPRIS
How to classify four common borderline products — hand sanitizer, mouthwash, personal lubricants, and data recorders — across FDA, EU MDR, Brazil ANVISA, and Mexico COFEPRIS. Includes decision trees, regulation citations, and jurisdiction-by-jurisdiction comparison tables.
Brazil ANVISA Medical Device Cost Breakdown 2026: Exact Fees for Classes I-IV, BGMP Audit Schedule, MDSAP Carve-Outs, ANATEL/INMETRO Add-Ons
The definitive 2026 cost reference for ANVISA medical device registration — exact government fees by class in BRL and USD, BGMP audit costs and schedules, MDSAP carve-outs, ANATEL wireless fees, INMETRO electrical safety certification, and Brazilian Registration Holder retainer ranges.
The CE + FDA Strategic Combo: How Holding Both Approvals Unlocks 25+ Markets and Cuts Time-to-Market 30-50%
Strategic analysis of dual CE Mark + FDA 510(k)/PMA approval showing the multiplier effect across 25+ markets, country grouping matrix, and concrete cost/timeline comparisons for manufacturers pursuing both pathways.
Combination Products (Drug-Device): Complete FDA & EU MDR Regulatory Guide (2026)
The complete guide to drug-device combination product regulation — FDA jurisdiction (OCP, RFD, 21 CFR Part 4), EU MDR Article 117, Notified Body Opinions, QMSR changes, CGMP requirements, market pathways, and post-market obligations.
EUDAMED Day Zero: The Role-Specific Action Playbook for Manufacturers, Authorized Representatives, Importers, and Distributors (Final 50 Days Before May 28, 2026)
Role-by-role action playbook for the May 28, 2026 EUDAMED mandatory deadline — covering actor registration, UDI/device registration, certificate uploads, and market surveillance obligations with a countdown checklist and member-state penalty matrix.
Where Does Your CE Mark Actually Get You? The Global Reliance Map for Medical Device Manufacturers
A strategic map of 25+ countries where CE marking provides regulatory leverage — organized by mechanism: full reliance, abridged review, evidence-only acceptance, and reference-only. Know which markets your CE Mark unlocks and what extra steps remain.
Human Factors Testing for Medical Devices: FDA Requirements, IEC 62366, and Validation Testing Guide (2026)
The complete guide to human factors testing for medical devices — FDA guidance, IEC 62366-1 usability engineering, formative and summative evaluations, sample size requirements, HF submission categories, and how to prepare documentation that passes regulatory review.
Indonesia AKD Medical Device Registration: When Halal Certification and CDAKB Are Actually Required (and When They're Not)
Busting the two biggest myths about Indonesian medical device registration — which devices actually need BPJPH Halal certification (not all of them), and whether CDAKB is a foreign manufacturer obligation or a local distributor obligation.
Missed the May 26, 2024 MDR Notified Body Deadline? Your Emergency Exit Options for Legacy MDD Devices
Operational playbook for manufacturers that missed the May 26, 2024 Notified Body written agreement deadline under Regulation (EU) 2023/607 — covering legal status of non-qualifying devices, market withdrawal timelines, fresh MDR application routes, sell-off rules, and specific examples by device class.