"The Regulations on the Supervision and Administration of Medical Devices" requires that "the quality management standards for the production of medical devices shall provide clear provisions on matters affecting the safety and effectiveness of medical devices, such as the design and development of medical devices, production equipment conditions, raw material procurement, production process control, enterprise organization, and staffing".
In the Manufacturing Quality Management Practice for Medical Devices, verification is defined as "identification that stipulated requirements have been met by providing objective evidence".
The concept of validation has been used for a long time in the field of drug production, and many professional papers have been published.
Validation work in the field of medical device production can refer to and learn from the experience of validation work in the field of drug production.
The general process of medical device production verification includes five steps: determining the purpose of evaluation -- defining the verification method -- formulating the verification plan -- implementing the verification work -- forming the verification report.
Process verification is one of the most important medical device verification work, the purpose is to verify the production process can be used to produce the stable quality of qualified products. It will continue throughout the medical device manufacturing process, generally in the form of pre-validation, and periodic revalidation is required.
For high-risk medical device products, sterility verification is particularly important, which is used to verify whether the sterilization process adopted (in special cases, the sterile production process is adopted) can ensure the sterility of all products eventually marketed and is a key link to ensure clinical safety.
In ethylene oxide sterilization of medical device manufacturing enterprise at present the most widely used, the temperature and humidity of ethylene oxide sterilization effect, validation, and pay attention to the related condition monitoring in daily production, in addition, to pay attention to the epoxy ethane flammable and toxic to the human body, should undertake in an airtight device and should be sufficient resolution after sterilization,
In general, the determination of the residual amount of ethylene oxide after parsing is included in the process verification of ethylene oxide.
It should be noted that the sterilized products need to be properly handled to avoid contamination after the sterilization process, and sterile products after the sterilization process need to be sterility checked before leaving the factory.