MedDeviceGuide — IVD & Medical Device Knowledge Base
Companion Diagnostics (CDx): Regulatory Pathways, Development, and Market Access
Guide to companion diagnostic regulation, including FDA approval pathways, EU IVDR requirements, therapeutic co-development, PMA and De Novo strategy, and market access evidence.
Medical Device Labeling & UDI System: The Complete Regulatory Guide
Understand FDA and EU MDR labeling requirements, UDI system setup, GUDID submissions, global UDI harmonization, compliance checklists, and common pitfalls.
Medical Device Policy & Legislation: Key Laws Shaping the Industry in 2026
Track medical device policy in 2026, from MDUFA V and VALID Act debates to EU MDR implementation, AI regulation, and global trends affecting market access.
Point-of-Care Testing (POCT): Regulatory Requirements, CLIA Waivers, and Market Trends
Guide to point-of-care testing regulation, including CLIA waivers, FDA pathways, EU IVDR classification, quality management, and near-patient market trends.
Sustainability & ESG in Medical Devices: Regulations and Best Practices
How sustainability, ESG reporting, and circular economy reshape medical device design, manufacturing, EU CSRD compliance, and lifecycle strategy.
AI/ML Medical Devices: FDA Framework, SaMD Classification, Approval Paths
Guide to AI and machine learning medical device regulation, covering FDA AI/ML policy, PCCPs, SaMD classification, 510(k), De Novo, EU MDR, and Good Machine Learning Practice.
CAPA for Medical Devices: Corrective and Preventive Action Complete Guide
CAPA guide for medical device quality systems, covering FDA QMSR, ISO 13485 clause 8.5, root cause analysis, CAPA steps, effectiveness checks, and common audit findings.
DHF, DMR, and DHR: Essential Medical Device Documentation Guide
Guide to DHF, DMR, and DHR documentation for medical devices, including FDA requirements, ISO 13485 equivalents, record contents, relationships, and practical implementation.
IEC 62366 Usability Engineering for Medical Devices: Complete Guide
Apply IEC 62366 usability engineering to medical devices, including the usability file, formative and summative evaluations, use-related risk analysis, FDA guidance, and EU MDR expectations.
Supplier Quality Management for Medical Devices: Audits, Qualification, and Controls
Medical device supplier quality guide covering FDA and ISO 13485 purchasing controls, qualification, audits, agreements, risk controls, and MDSAP expectations.
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: 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.