What Is a 513(g) Request for Information?
A 513(g) request for information helps clarify FDA device classification and requirements, giving you guidance before choosing a regulatory pathway.
Regulation
CAPA System Development: A Step-by-Step Guide
Get practical steps for CAPA system development, from planning and documentation to team training and compliance, in this clear, actionable guide.
The Essential Guide to the 510(k) Summary
Get clear answers on the 510(k) summary—what it is, why it matters, and how to prepare a strong one for your medical device FDA submission.
What is a GxP Gap Assessment? A Simple Guide
A GxP gap assessment helps you spot compliance gaps, improve quality systems, and prepare your team for audits with clear, actionable steps.
What Are FDA US Agent Services? A Complete Guide
Get clear answers about US agent services FDA requires for foreign companies. Learn what a US agent does and how to choose the right partner for compliance.
Your Guide to the Abbreviated 510(k) Submission
Get clear, actionable steps for your abbreviated 510(k) submission. Learn requirements, benefits, and tips to help your medical device reach the market.
Your 510(k) Submission: A Step-by-Step Guide
Get clear, actionable steps for your 510(k) submission. Learn what to include, how to avoid common mistakes, and tips for a smooth FDA review process.
How to Create an ISO 14971 3.4 Risk Management Plan
Get a clear, actionable overview of the iso 14971 3.4 risk management plan for medical devices, with practical steps for compliance and safer products.
How to Write a Clinical Evaluation Plan That Works
A clinical evaluation plan is the foundation for medical device approval. Learn what a clinical evaluation strategy is and why it matters for compliance.
Does Your Device Modification Qualify for a Special 510(k)?
Learn how the special 510 k device modification process works, who qualifies, and what steps to take for a faster FDA review of your medical device changes.