Reducing the Life Cycle Cost of Validation:
Part 1 – Appropriate Material Selection and Part Design
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, such as 21 CFR 820. 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. By completing each phase of this process, you not only greatly increase the chance of a successful validation, but you can also ensure quality for the life of the product. Several key areas with specific criteria are critical to the process, yet they are often overlooked or underestimated. In this segment of the series, we will review some of the important details you should consider during material selection and part design.