United States
295 articles
Medical Device Regulatory Consulting Hourly Rates by Region (2026)
Benchmark medical device regulatory consulting rates by region and consultant tier, with cost drivers and budgeting guidance for registration projects in major markets.
US Government Medical Device Procurement: GPOs, FSS and Market Access
Guide to US public-sector device procurement through GPOs, VA Federal Supply Schedules, DoD channels, GSA contracts and SAM.gov registration.
Real-World Evidence for Medical Devices: FDA RWE Guidance and Regulatory Uses
Guide to using real-world evidence and real-world data in medical device submissions, including FDA guidance, data sources, reliability criteria, and regulatory strategy.
FDA Form 483 and Warning Letter Response Guide for Medical Devices
Guide to responding to FDA Form 483 observations and Warning Letters for medical devices, including 2025-2026 enforcement trends, top violations, response strategy, and draft guidance.
FDA User Fees 2026: MDUFA Fee Schedule and Small Business Planning
Plan FY 2026 medical device user fees with MDUFA V fee amounts, small business reductions, PMA waivers, registration fees, and cost controls.
PMA Submission Cost: Complete 2026 Budget Breakdown for Class III Devices
Budget FDA PMA submissions for Class III devices with FY 2026 user fees, clinical trial costs, testing, consulting, post-market obligations, and planning benchmarks.
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.