


Steps for Successfully Developing and Designing In Vitro Diagnostic Products
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...
Medical Device Validation and Verification Requirements
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...
What’s the Difference Between the FDA Medical Device Classes?
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...
3 Types of FDA Inspections and What That Means for Medical Manufacturing Companies
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...