Medical Device & IVD Blog
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.
How to Choose a Medical Device Regulatory Consultant: Complete 2026 Evaluation Guide
Evaluate medical device regulatory consultants with selection criteria, interview questions, red flags, pricing benchmarks, RAC/RAPS signals, and a stage-based decision framework.
In-House vs Outsourced Regulatory Affairs for Device Companies
Compare in-house, outsourced, and hybrid regulatory affairs models for medical device companies, with 2026 cost benchmarks, market data, stage-based fit, and decision guidance.
Indonesia Medical Device Registration: The Complete Guide for Foreign Manufacturers
Guide to registering medical devices in Indonesia, covering BPOM/MoH classification, CSDT dossiers, Regalkes submissions, local representatives, Halal deadlines, and market entry.
ISO 13485 Certification Cost & Timeline: Complete 2026 Guide
Breakdown of ISO 13485 certification costs and timelines, including certification body fees, consulting rates, surveillance audits, hidden expenses, and cost-saving strategies.
Mexico COFEPRIS Medical Device Registration: The Complete Guide
Register medical devices with Mexico COFEPRIS, including classification, standard and equivalency routes, registration holder duties, fees, fast-track options, and 2026 market entry planning.
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.
ISO 10993-1:2025: What Changed, Why It Matters, and How to Prepare
Practical guide to ISO 10993-1:2025 changes, including risk-based biological evaluation, the new table framework, exposure duration updates, genotoxicity, and compliance steps.
EU IVDR Classification Rules: The Complete Guide to IVD Risk Classes A–D
Practical guide to IVDR Annex VIII classification rules for IVD Classes A-D, with device examples, software guidance, IVDD-to-IVDR changes, and the 2025 EU simplification proposal.
EU MDR Notified Bodies and Conformity Assessment Guide
Guide to EU MDR Notified Bodies and conformity assessment, including NB selection, routes by device class, audits, timelines, costs, and 2025-2026 regulatory context.
EUDAMED Registration Guide for Medical Device and IVD Manufacturers
Step-by-step EUDAMED registration guide covering SRN actor registration, UDI/device data, Notified Body certificates, market surveillance, May 2026 deadlines, and legacy devices.
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.
ISO 13485 Internal Audit Guide: Checklist, Process, and Best Practices
Guide to ISO 13485 internal audits, including Clause 8.2.4 expectations, audit planning, checklists, auditor qualifications, nonconformities, CAPA linkage, and certification readiness.
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.