Tag: medical device manufacturing

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ISO 9001: Frequently Asked Questions Answered

As with any industry, medical device manufacturers are governed by industry standards and government regulations. Chief among these standards is ISO 9001—the international standard for quality management systems for companies, businesses, and organizations. ISO first published the standard in 1987. Updated versions were published in 1994, 2000, 2008, with the newest version being ISO 9001:2015…. Read more »

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What Makes the Top Medical Device Companies Succeed?

What makes top medical device companies successful? The first answer for most would likely be profit, but profit is a product of success, not the key to success. Given the complexity of developing medical devices, the challenges companies face from concept to production to regulatory approval to market are many. Today’s healthcare industry is fluid…. Read more »

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How Statistical Process Control Helps Medical Device Manufacturers Maintain Quality

Statistical process control (SPC) has proven to be an effective means for original equipment manufacturers (OEM) of medical devices to maintain and even improve product quality. SPC utilizes statistical methods, quantitative and graphic analysis of measurements, to evaluate and assess the stability of a process and the resulting quality of its production. Manufacturers that implement… Read more »

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 »