Introduction - To legally place a medical device on the market in the European Union, a device must bear the CE marking, which is the manufacturer's declaration that the product…

Introduction to ISO 13485 - ISO 13485 is an internationally recognized standard that sets forth the requirements for a quality management system (QMS) specifically tailored to the medical device industry.…

Introduction - A Unique Device Identification (UDI) system is meant to offer a single, internationally harmonized system for identifying medical devices through distribution and usage, according to the International Medical…

INTRODUCTION - The approach taken to address biological risk, or biocompatibility, for medical devices is described in depth in the Biological Evaluation Plan. The medical device's configuration, material composition, manufacturing…

A typical path to MDD compliance was claiming medical device equivalency, which spared businesses the time and expense of producing fresh clinical data. But since the EU MDR came into…

Introduction - The FDA may receive several submissions about newly developed or altered medical devices being marketed in the United States. The two most popular forms of market authorization submissions…

Introduction - Manufacturers of medical devices are subject to regulations worldwide to protect the consistency of their products. Manufacturers require a well-organized quality management system to do this. It is…

Introduction - The FDA typically requires you to complete a 510k submission or seek premarket approval for your medical device if you intend to manufacture or distribute it within the…

Introduction - The Food and Drug Administration (FDA) guarantees the efficacy and safety of medications, biologics, and medical devices. The FDA's medical device regulatory procedure is a significant obstacle to…

Introduction - An FDA premarket submission is called a 510(k). Because it alludes to that particular portion of the Food, Drug, and Cosmetic Act, it is known as a 510(k).…