Tag: medical device process validation

Test Tubes

Product and Services Spotlight: Sample Preparation Device Design and Testing

Sample preparation in medical device design and testing serves as an investigative procedure to assess qualitative and quantitative measures and performances. Safety and quality are the preeminent factors in the medical device manufacturing industry. Stringent regulatory requirements are in place for every phase of a device’s life cycle, including design and testing. OEMs (Original Equipment… Read more »

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 »

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 »