Consistent quality manufacturing is considered the key to the safety and effectiveness of medical devices, and regulatory agencies around the world, including the FDA, want to see the process of manufacturing conformance and document validation for medical device manufacturers. ISO13485 is designed to ensure higher quality and consistency in the manufacture of therapeutic device products.
Under the ISO13485 standard, our engineers can easily integrate our test equipment into the process validation of your company's medical device manufacturing. Our equipment is successfully used in IQ, OQ and PQ qualifications, as well as in evaluating repeatability and reproducibility activities, and our highly trained engineers can provide quick and comprehensive assistance in these high-risk processes.
What is ISO13485 and its importance:
Consistent quality manufacturing is considered the key to the safety and effectiveness of medical devices, and regulatory agencies around the world, including the FDA, want to see the process of manufacturing conformance and document validation for medical device manufacturers. ISO13485 is designed to ensure the high quality and consistency of the manufacture of therapeutic device products. It is often combined with ISO 9001 to form a comprehensive ISO quality management system within the company.
Formal process validation includes installation certification (IQ), operational certification (OQ), and performance certification (PQ). In installation certification (IQ), each machine on the production line needs to be properly connected to the application and assembled on the production line. The installation instructions are taken from the equipment manufacturer and the documentation includes these suitable installation activities. And calibration certificate. Operational Qualification (OQ) involves operating the machine in accordance with the machine manufacturer's design and instructions to ensure that it operates as expected. Performance Qualification (PQ) involves verifying changes in machine operation based on normal process changes, which typically requires three different operators to operate the machine in the same way as the surface and record any differences in operational results.
We can help
TestResources test equipment is often used online for medical device manufacturing process validation, a common example of which is to ensure compliance with each aseptic package seal. We can help your company provide formal process validation by providing equipment, IQ checklists and other relevant documentation.
TestResources is well versed in the medical device manufacturing industry and provides a large number of equipment for many of these companies to participate in its ISO 13485 process. Our professional engineers know that the ISO13485 verification process is time consuming and time consuming, so they are always available to provide expert advice and help you quickly verify your manufacturing process. Providing timely and free testing solutions makes us look different!
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