Medical Device & IVD Blog

An independent, unbiased comparison of the top eQMS platforms for medical device companies in 2026 — covering Greenlight Guru, MasterControl, Qualio, QT9 QMS, ComplianceQuest, Arena QMS, and more. Includes pricing, features, ISO 13485 and QMSR readiness, and recommendations by company size.

Everything you need to know about marketing medical devices in France in 2026 — including EU MDR requirements, ANSM registration, EUDAMED deadlines, French-language labeling mandates, CNEDiMTS and CEPS reimbursement pathway, LPPR listing, clinical investigation procedures, materiovigilance obligations, and practical market entry guidance for Europe's second-largest medical device market.

Everything you need to know about marketing medical devices in Germany in 2026 — including EU MDR requirements, BfArM and PEI responsibilities, MPDG national law, German-language labeling mandates, DMIDS and EUDAMED registration, clinical investigation procedures, DiGA digital health pathway, and practical market entry guidance for Europe's largest medical device market.

Everything you need to know about registering medical devices in Israel in 2026 — including AMAR classification, declaration and fast-track routes, Israel Registration Holder (IRH) requirements, reference country approvals, SII certification, labeling in Hebrew, Arabic, and English, and step-by-step registration instructions.

Everything you need to know about marketing medical devices in Italy in 2026 — including EU MDR requirements, Ministry of Health national registration via BD/RDM (Repertorio) database, EUDAMED deadlines, Italian-language labeling mandates, national HTA program (PNHTA-DM), clinical investigation procedures, post-market surveillance, and practical market entry guidance for Europe's fourth-largest medical device market.

Everything foreign manufacturers need to know about Korea Good Manufacturing Practice (KGMP) certification in 2026 — including MFDS requirements, application process, document checklist, audit types, costs, timeline, and how to prepare for the updated 2026 GMP regulations.

Everything you need to know about registering medical devices in Malaysia in 2026 — including MDA classification (Class A–D), CAB conformity assessment, MeDC@St submissions, verification pathway, Singapore reliance route, authorized representative requirements, fees in RM, and step-by-step registration instructions.

Everything you need to know about marketing medical devices in the Netherlands in 2026 — including EU MDR requirements, IGJ oversight, CIBG Farmatec and NOTIS national registration, Dutch-language labeling mandates, EUDAMED deadlines, clinical investigation procedures via CCMO, post-market surveillance, Dutch notified bodies (BSI, DEKRA, Kiwa), and practical market entry guidance for one of Europe's most important medical device hubs.

Everything you need to know about registering medical devices in the Philippines in 2026 — including PFDA/CDRRHR classification (Class A–D), CMDN vs CMDR pathways, ASEAN AMDD alignment, LTO requirements, English-language submissions, fees in PHP, and step-by-step registration instructions.

Everything you need to know about registering medical devices in Singapore in 2026 — including HSA classification (Class A–D), evaluation routes (Immediate, Abridged, Expedited, Full, Priority Review), CSDT requirements, dealer's licence obligations, SHARE portal submissions, fees in SGD, and step-by-step registration instructions.

Everything you need to know about marketing medical devices in Spain in 2026 — including EU MDR requirements, AEMPS national registration database, Royal Decree 192/2023, EUDAMED deadlines, Spanish-language labeling mandates, clinical investigation procedures, post-market surveillance, autonomous region distributor notifications, and practical market entry guidance for one of Europe's largest healthcare markets.

Everything you need to know about registering medical devices in Thailand in 2026 — including Thai FDA classification (Class 1–4), CSDT requirements, establishment licensing, e-Submission system, fees in THB, auto-approval for Class 1, Medical Device Act B.E. 2551, local importer obligations, and step-by-step registration instructions.

Everything you need to know about registering medical devices in Vietnam in 2026 — including MFDS/MOH requirements, Decree 98/2021, classification (Class A–D), fast-track pathways, 50% fee reduction, CSDT requirements, local representative obligations, and step-by-step registration instructions.

A data-driven breakdown of every cost component for CE marking under EU MDR — notified body fees, clinical evaluation, technical documentation, authorized representative, ISO 13485, and ongoing compliance costs with 2026-specific figures.

A comprehensive guide to EU Authorized Representative (EC REP) requirements under EU MDR and IVDR. Covers Article 11 obligations, mandate requirements, costs, PRRC obligations, EUDAMED registration, and how to select the right EU AR for your medical device or IVD company.

A complete guide to EU MDR and IVDR transition deadlines for legacy devices. Covers Article 120 MDR and Article 110 IVDR transitional provisions, class-specific deadlines, conditions for eligibility, EUDAMED requirements, and practical steps to maintain EU market access.

Learn how to respond to FDA Form 483 observations and Warning Letters for medical devices. Covers 2025-2026 enforcement statistics, top violations, response strategies, and the March 2026 draft guidance on 483 responses.

Everything you need to know about FDA medical device user fees for FY 2026 (October 2025–September 2026) — covering the complete MDUFA V fee schedule, small business determination program, first PMA waiver, new establishment registration fee waiver, year-over-year comparisons, and strategies to minimize your regulatory costs.

A practical guide to evaluating and selecting a medical device regulatory consultant — covering key criteria, questions to ask, red flags to avoid, pricing benchmarks, certifications (RAC, RAPS), and a decision framework for companies at every stage.

A decision framework for choosing between in-house, outsourced, and hybrid regulatory affairs models — with 2026 cost comparisons, market data, and practical guidance for medical device manufacturers at every stage.