Author: BMP Medical

Medical Markets Working in Lab | Medical Device Process Validation

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 term that indicates that a product, service or other outcome has been subjected to such scrutiny… 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.

BMP Medical to Attend DeviceTalks Exhibit

As an OEM medical device manufacturer, the BMP Medical Team will attend the DeviceTalks Exhibit at the Westin Waterfront in Boston this October. This event is a can’t-miss opportunity for companies in the MedTech community as it fosters the exchange of ideas, insight as well as technology information among biomedical industry pioneers.

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 »