By PTI Engineered Plastics
Reliable medical devices and equipment are essential for researchers and doctors to accurately diagnose and treat a wide range of diseases. That is why there is such stringent oversight from the FDA to ensure these products meet the necessary requirements and specifications. To ensure compliance with regulators, manufacturers follow installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) guidelines. IQ/OQ/PQ certifies the necessary equipment is present and the manufacturing process to create devices that consistently perform to the desired specifications. Several key areas with specific criteria are critical to the process, yet they are often overlooked or underestimated.
Material Selection:
First and foremost, availability is a key factor when it comes to material selection for a medical device. It is important to choose a material that is widely available in the market in wh…