Medical Device & IVD Blog
ISO 13485 Audit Findings: Most Common Nonconformities by Clause and How to Prevent Them
The ISO 13485 clauses most cited in audit findings — root causes and corrective actions for document control, CAPA, design controls, suppliers, internal audits, and process validation.
FDA 510(k) Consultants: How to Choose, Vet, and Work with a Clearance Partner
How to select, evaluate, and engage an FDA 510(k) consultant — fees by device complexity, engagement models, red flags, due diligence checklist, and when hiring one makes financial sense.
FDA Adverse Event Monitoring System (AEMS): What Replaced MAUDE for Medical Devices
FDA replaces MAUDE with AEMS — unified adverse event dashboard, migration timeline, data limitations, and reporting changes for device manufacturers.
Medical Device Software Verification vs Validation: FDA and IEC 62304 Requirements
Software verification vs validation for medical devices — FDA expectations, IEC 62304 activities, documentation, traceability, and the design control process.
FDA 510(k) Clearances: Tracking, Timelines, and Decision Data
Track FDA 510(k) clearances, understand review timelines, interpret SE/NSE decisions, use the 510(k) database, and apply clearance statistics to your 2026 regulatory strategy.
FDA 510(k) Guidance Documents: Device-Specific Requirements and Special Controls
How to find and use FDA 510(k) guidance documents, Class II special controls, device-specific submission requirements, and the CDRH FY 2026 guidance agenda to prepare stronger premarket submissions.
FDA Medical Device Registration: Step-by-Step Process from Classification to Market
Step-by-step FDA medical device registration — classification, 510(k)/De Novo/PMA pathways, establishment registration, device listing, FY 2026 fees, and post-market obligations.
Dermal Fillers vs Cosmetics vs Medicines: Hong Kong Borderline Classification After GN-00
How Hong Kong classifies injectable dermal fillers at the borderline between medical devices, cosmetics, and medicines — and why the May 2026 GN-00 update matters for your product.
eDHR for Medical Devices: QMSR, Part 11 & Digital Manufacturing (2026)
eDHR implementation guide for medical device manufacturers: QMSR requirements, 21 CFR Part 11, MES integration, ISO 13485, paper-to-digital migration, and inspection readiness.
NAMs for Medical Device Biocompatibility: FDA, EU & ISO 10993 Guide (2026)
NAMs for medical device biocompatibility: FDA roadmap, EU phase-out plan, ISO 10993-5/-10/-23 in vitro alternatives, chemical characterization, and regulatory strategy.
Hong Kong Dermal Filler MDACS Listing Strategy: LRP, Docs, Importers, Procurement
Guide to listing injectable dermal fillers under Hong Kong MDACS after the May 2026 GN-00 update: LRP, technical dossier, importer controls, adverse event reporting, and procurement.
Hong Kong MDACS GN-00 Update: Why Injectable Dermal Fillers Are Now Medical Devices
On 13 May 2026, Hong Kong MDD updated GN-00 to classify injectable dermal fillers as medical devices under MDACS. What changed, why it matters, and what manufacturers must do.
RPM Device Regulatory Pathway: FDA, CMS Reimbursement & EU MDR (2026)
RPM device regulation: FDA classification, CMS 2026 CPT codes (99445, 99470), reimbursement rates, SaMD, EU MDR pathway, and commercialization strategy for connected monitoring devices.
Abbott Libre Duo CE Mark: Dual Glucose-Ketone CGM Strategy (2026)
Abbott Libre Duo CE mark analysis covering the first continuous glucose-ketone sensor, dual-analyte regulatory strategy, CGM competition, FDA pathway, and wearable convergence.
EU Digital Product Passport for Medical Devices: ESPR, Batteries, and UDI
Guide to EU Digital Product Passport requirements for medical devices, including ESPR scope, battery passports, UDI/EUDAMED links, standards, and timelines.
Liquid Biopsy and Multi-Cancer Early Detection (MCED) Tests: FDA, IVDR Regulatory Pathway
Regulatory guide to liquid biopsy and MCED tests, including FDA pathways, Breakthrough designation, companion diagnostics, EU IVDR classification, clinical evidence, and key market players.
Quantum Surgical Acquires NeuWave Medical: Precision IO and Robotic Ablation
Quantum Surgical's 2026 NeuWave acquisition pairs Epione robotic ablation with microwave ablation technology under Precision IO Group for interventional oncology.
Swissmedic 2026 PMS Focus Campaign: What Class IIa/IIb/III Manufacturers Must Prepare Now
Swissmedic 2026 PMS focus campaign guide for Class IIa, IIb, and III devices, covering PMS plans, PSURs, PMCF data, complaints, trend analysis, and preparation.
Thermo Fisher Microbiology Divestiture to Astorg: $1.1B Deal Analysis
Analysis of Thermo Fisher's $1.1B microbiology divestiture to Astorg, including deal terms, Oxoid and Remel assets, $645M revenue, and diagnostics strategy.
EUDAMED Mandatory Registration: May 28, 2026 Deadlines and UDI Steps
Guide to mandatory EUDAMED registration from May 28, 2026, including actor registration, UDI/device data, certificate linkage, legacy device deadlines, and action steps.