Regulatory
567 articles
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.
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.
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.
The Complete Guide to FDA 510(k) Submissions
Practical FDA 510(k) submission guide covering predicate selection, substantial equivalence, eSTAR formatting, user fees, common deficiencies, and first-time filing 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.
MDSAP Audit: The Complete Guide to the Medical Device Single Audit Program
Everything about MDSAP — the single audit program covering FDA, Health Canada, TGA, ANVISA, and MHLW. Audit process, grading, preparation, costs, and how to pass.
FDA's QSR to QMSR Transition: What Medical Device Companies Need to Know
The FDA is aligning its Quality System Regulation with ISO 13485. Here's what the QMSR final rule means for your quality management system and what you need to do to prepare.
South Korea MFDS Medical Device Approval: The Complete Guide
Navigate South Korea's medical device regulatory system — MFDS classification, KGMP, approval pathways, clinical requirements, and practical market entry guidance.
Australia TGA Medical Device Registration: The Complete Guide
How to register medical devices with Australia's TGA — classification, ARTG inclusion, sponsor requirements, MDSAP, fees, and practical guidance for the Australian market.