Medical Device & IVD Blog
510(k) Predicate Devices: How to Find, Evaluate, and Select the Right Predicate
Step-by-step guide to finding and selecting predicate devices for FDA 510(k) submissions — search strategies, substantial equivalence criteria, split predicates, and common selection mistakes.
CE Marking for Medical Devices: Requirements, Process, and Conformity Assessment Under EU MDR
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: The Complete Guide to Regulations, 510(k), and Special Controls
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 Requirements, Clinical Evidence, and the Path to 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: Pathway Requirements, Process, and How to Create a New Device Category
The complete guide to FDA's De Novo classification pathway — when to use it, application requirements, special controls development, review timelines, and how De Novo creates new predicates for future devices.
FDA MAUDE Database: The Complete Guide to Searching and Using 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: How to Look Up Device Classification, Regulation Numbers, and Exemption Status
The complete guide to FDA product codes — how to search the Product Classification Database, understand device classification, check 510(k) exemption status, and determine your regulatory 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, Threat Modeling, and Compliance Guide
The complete guide to medical device cybersecurity regulations — FDA Section 524B requirements, SBOM, threat modeling, premarket submissions, post-market vulnerability management, and EU MDR cybersecurity obligations.
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
A detailed comparison of FDA's PMA and 510(k) pathways — clinical evidence requirements, review timelines, costs, post-market obligations, and a decision framework for choosing the right route to market.
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 — The Complete Guide for Medical Device Companies
Everything you need to know about ISO 13485 certification: requirements by clause, the certification process step-by-step, costs, timelines, how to choose a registrar, common audit findings, and how ISO 13485 fits with FDA QSR, EU MDR, and MDSAP.