Medical Device & IVD Blog
CE Marking for Medical Devices: EU MDR Requirements, Process, and Assessment
The complete guide to CE marking medical devices under EU MDR — classification, conformity assessment routes, Notified Body selection, technical documentation, and step-by-step process.
Design Controls for Medical Devices: FDA Requirements, Process, and Implementation Guide
The complete guide to medical device design controls — FDA 21 CFR 820.30, ISO 13485 clause 7.3, the design control process, DHF requirements, traceability, and practical implementation.
FDA 510(k) Database: How to Search, Find Predicates, and Use Clearance Data
Step-by-step guide to searching the FDA 510(k) database — finding predicate devices, reading clearance summaries, using openFDA API, and leveraging 510(k) data for regulatory strategy.
FDA Class I Medical Devices: General Controls, Exemptions, and Regulatory Requirements
The complete guide to FDA Class I medical devices — general controls, 510(k) exemptions, GMP requirements, device listing, and what 'low risk' really means for regulatory compliance.
FDA Class II Medical Devices: 510(k), Special Controls, and Rules
Everything you need to know about FDA Class II medical devices — special controls, 510(k) requirements, exemptions, device examples, and how to navigate the regulatory pathway.
FDA Class III Medical Devices: PMA, Clinical Evidence, and Approval
The complete guide to FDA Class III medical devices — PMA applications, clinical trial requirements, pre-amendment devices, user fees, and what makes Class III the highest-risk regulatory category.
FDA De Novo Classification: Requirements, Process, and New Device Categories
Guide to FDA De Novo classification, including when to use the pathway, application requirements, special controls, review timelines, and how De Novo creates future predicates.
FDA MAUDE Database: Search and Use Medical Device Adverse Event Reports
How to search, interpret, and use the FDA MAUDE database — report types, data fields, search techniques, limitations, and practical applications for regulatory professionals.
FDA Product Codes: Classification, Regulation Numbers, and Exemptions
Use FDA product codes to confirm device classification, regulation numbers, 510(k) exemption status, and the likely premarket pathway.
ISO 13485 vs ISO 9001: Key Differences, Requirements, and Which Standard You Need
A detailed comparison of ISO 13485 and ISO 9001 — clause-by-clause differences, regulatory requirements, when you need each standard, and how to transition between them.
In Vitro Diagnostic (IVD) Devices: The Complete Regulatory Guide for FDA and EU IVDR
Everything you need to know about IVD device regulations — FDA classification, EU IVDR classes A-D, performance evaluation, companion diagnostics, LDTs, and global regulatory requirements.
Medical Device Cybersecurity: FDA Requirements, SBOM and Compliance Guide
Learn FDA Section 524B cybersecurity expectations for medical devices, including SBOMs, threat modeling, premarket evidence, vulnerability management, and EU MDR alignment.
Medical Device GMP: Manufacturing Requirements, FDA Inspections, and Compliance Guide
The complete guide to Good Manufacturing Practice for medical devices — 21 CFR 820, QMSR transition, process validation, FDA inspections, Form 483 observations, and practical compliance strategies.
PMA vs 510(k): Differences, Requirements, and How to Choose the Right FDA Pathway
Compare FDA PMA and 510(k) pathways by evidence requirements, review timelines, costs, post-market duties, and decision criteria for US market entry.
China NMPA Medical Device Registration: The Complete Guide for Foreign Manufacturers
How to register medical devices with China's NMPA — classification, documentation, clinical requirements, testing, timelines, costs, and practical guidance for market entry.
ISO 14971 Risk Management for Medical Devices: The Complete Guide
A comprehensive guide to implementing ISO 14971 risk management for medical devices — from hazard identification through risk control to post-production monitoring.
Japan PMDA Medical Device Approval: The Complete Guide
Navigate Japan's medical device approval system — PMDA pathways, QMS requirements, MAH structure, clinical trials, reimbursement, and practical market entry guidance.
Health Canada Medical Device License: The Complete Guide
How to obtain a Medical Device License from Health Canada — classification, MDSAP requirements, MDEL, application process, fees, and practical guidance for the Canadian market.
ISO 13485 Certification: Complete Guide for Medical Device Companies
Guide to ISO 13485 certification requirements, audit process, costs, timelines, registrar selection, common findings, and alignment with FDA QSR, EU MDR, and MDSAP.
Software as a Medical Device (SaMD): The Complete Regulatory Guide
Guide to SaMD regulation covering IMDRF classification, FDA and EU MDR pathways, IEC 62304, IEC 82304-1, AI/ML change control, cybersecurity, and global frameworks.