Regulatory
31 articles
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.
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.
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.
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.
Software as a Medical Device (SaMD): The Complete Regulatory Guide
Everything you need to know about SaMD regulation — IMDRF classification, FDA pathways, EU MDR Rule 11, IEC 62304, IEC 82304-1, AI/ML frameworks, PCCP, Digital Health Center of Excellence, international SaMD frameworks (UK, Canada, Japan, Australia), cybersecurity, real product examples, and practical implementation guidance.
The Complete Guide to FDA 510(k) Submissions
Everything you need to know about the FDA 510(k) process — from predicate device selection and substantial equivalence to eSTAR formatting, user fees, common deficiencies, and first-time submission tips.
Brazil ANVISA Medical Device Registration: The Complete Guide
How to register medical devices with ANVISA — classification, B-GMP via MDSAP, registration pathways, documentation, fees, and practical guidance for the Brazilian market.