There’s little doubt that the medical device manufacturing industry is expanding worldwide and contract manufacturing services a large part of it. Over the past several decades, the industry, and the contract manufacturing sector has met the challenges of ever-increasing demand and reshaped medical technology. There are near 5,800 companies employing over 350,000 people in the… Read more »
For over 30 years, BMP Medical has produced components for in vitro diagnostic medical devices testing. In vitro diagnostic (IVD) products are those reagents, instruments, and systems intended for use in diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, detect, treat, or prevent disease,… Read more »
Original Equipment Manufacturers (OEM) of medical devices must perform and pass FDA approved medical device process validation and verification before any product can be introduced on the market. In the medical device industry, process validation and verification is a term that indicates that a product, service or other outcome has been subjected to such scrutiny… Read more »
All medical devices sold in the United States are regulated by the U.S. Food and Drug Administration (FDA). More specifically, any medical device manufactured, repackaged, relabeled, and/or imported by any company or firm to sell in the U.S. has to meet FDA regulations.
Medical manufacturing companies know the consequences of failing to adhere to FDA (The U.S. Food and Drug Administration) regulations can have severe repercussions. One glance at the U.S. Department of Justice and the U.S. Department of Health and Human Services joint annual report on health care fraud and abuse control shows approximately $3.3 billion in… Read more »