United States
429 articles
Top Medical Device Companies in 2026: Revenue Rankings, Market Share, and Industry Trends
2026 ranking of the largest medical device companies by revenue, with market share context, strategic shifts, and growth drivers across global medtech.
How Much Does a 510(k) Cost? Complete 2026 Budget Breakdown
Budget a 510(k) submission with 2026 FDA user fees, testing, consulting, hidden costs, small business savings, and practical cost-control strategies.
FDA Breakthrough Device Designation: Program Guide for 2026
Guide to FDA Breakthrough Device Designation in 2026, including eligibility criteria, Q-Submission application steps, program benefits, timelines, statistics, and pathway strategy.
FDA Medical Device Recalls: Corrections, Removals, and Classification
Guide to FDA medical device recalls under 21 CFR 7, 806, and 810, including voluntary and mandatory recalls, Class I/II/III classification, reporting, strategy, and compliance.
FDA Pre-Submission Guide: Get Feedback Before a Device Submission
Guide to FDA's Q-Submission program for medical devices, including Pre-Subs, Submission Issue Requests, Information Meetings, feedback requests, content, timelines, fees, and meeting strategy.
FDA Medical Device Reporting: Adverse Event Rules Under 21 CFR Part 803
Guide to FDA Medical Device Reporting under 21 CFR Part 803, including reportable events, 30-day and 5-day deadlines, eMDR submissions, MAUDE, and enforcement risk.
Medical Device Change Control: FDA and EU MDR Requirements
Guide to medical device change control for design, process, and regulatory changes, including FDA QMSR, EU MDR significant changes, Notified Body notification, and best practices.
Medical Device Shelf Life and Stability Testing Guide
Plan shelf life and stability testing for medical devices, including ASTM F1980 accelerated aging, real-time studies, sterile barrier testing, packaging validation, and expiration dating.
Medical Device Technical File: EU MDR Documentation Guide
Prepare EU MDR technical documentation for medical devices, including Annex II and III content, FDA DHF comparisons, STED format, ISO 13485 files, and practical assembly steps.
Medical Device Clinical Trials: FDA IDE Requirements Guide
Understand FDA IDE requirements, 21 CFR 812 risk categories, study design, ISO 14155 alignment, submission steps, costs, and clinical trial timelines.
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.
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.
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.