STEPS TO GET A CE CERTIFICATE
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…
ISO 13485: Enhancing Quality in the Medical Device Industry
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.…
UDI (Unique Device Identifier) in Medical Devices
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…
A ND Global Guide on Biological Evaluation
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…
Equivalence Demonstration of medical device
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…
FDA submission types for medical devices
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…
ISO 13485 vs. CFR Part 820
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…
510 (k) VS PMA: Major differences
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…
Types of 510(k) Overview
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 to 510 (k) Submission
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).…
