Tag: medical device manufacturing

Medical Diagnostics | in vitro diagnostic medical devices

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 determination of the state of health, in order to cure, mitigate, detect, treat, or prevent disease,… Read more »

Complex Injection Molding

5 Questions for OEM Medical Device Injection Molding

Injection molding is a manufacturing process that produces plastic injection molds from both thermoplastic and thermosetting polymers. Over the past several decades the method has proven to be the most cost-effective and best way for mass production of high-quality products with complicated shapes and is ideally suited for the production of medical devices. Precision-machined injection… Read more »

Class 1 Medical Devices

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 regulations.

Precision Plastic Parts

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 annual report on health care fraud and abuse control shows approximately $3.3 billion in… Read more »

Clean Room Manufacturing

How to Create an Easy Transition From the Validation Process to Manufacturing

One of the most important phases of a medical product development life cycle is the relationship between your company’s validation expert and the original equipment manufacturer (OEM) of your medical product. It is the test run for approval and commercialization. The importance of the transition from validation process to manufacturing will determine FDA approval, the… Read more »