Importing Medical Devices into the United States

The import of medical devices into the United States is a crucial aspect of the healthcare industry. However, importing these products can be a complex process.

Medical Device Risk Analysis

Let's take a deeper dive into medical device risk analysis, including its purpose, process, and the FDA-recognized standard ISO 14971.

UDI for Class I Devices

UDI, FDA requirements, and meeting FDA deadlines for UDI

Vision28 Checklist for FDA FORM 483 responses

FDA Inspections, FDA FORM 483, and Warning Letters Medical Device Manufacturers

Medical Device Single Audit Program

What is MDSAP?

Vision28 510(k) Process Overview

What data does the company need to provide Vision28 for a 510(k)?