Process verification is the most important kind of medical device verification work, and its purpose is to verify whether the adopted production process can stably produce qualified products. Process verification is a synthesis of many key process verifications. One of the key points in drawing up a process verification plan is to determine the key processes. Generally, selection has the greatest impact on product quality, or additional processes such as components and key circuit connections are added.

Process verification continues throughout the entire medical device production process. It is generally carried out in the form of pre-verification, and re-verification is required on a regular basis. For continuous multiple processes, there are two verification methods. One is that each batch completes the entire process of product production, and each key process is sampled to test and monitor the parameters of production equipment, product testing parameters or production equipment. The parameters should be within a fixed range. If the process is stable and reliable, the product or monitoring parameters of multiple batches (usually three batches) for process verification are within a relatively stable qualified value range. Another verification method is to verify each key process individually. After all the key processes are verified, the quality of the continuously produced product is continuously tested according to the verification parameters. For example, there are 4 key processes in a product production process. During process verification Each is verified individually. Prepare three batches of samples to be processed for the process verification of the first process. After the first process is qualified, the processed three batches of samples are subjected to the process verification of the second process, and the third and fourth process verifications are performed similarly.

At present, most medical device manufacturers learn from the experience of drug production process verification and adopt the first method. However, for many equipment-type medical device products, especially combination and assembly products, the second method is more effective for the key steps of the process. authenticating.