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Product validation


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Axxicon is proud to be ISO 13485 certified, which means that we have established and implemented a quality management system that meets the rigorous requirements of this internationally recognized standard.


This certification shows our commitment to providing the highest quality precision injection molds and services to the medical device industry. By being ISO 13485 certified, we are able to produce precise medical products that are compliant with this standard. Our product validation process is designed to ensure that your products meet the strictest quality standards and regulatory requirements, providing you with the confidence and assurance that they need for medical device products.


At Axxicon, we are dedicated to providing you with the highest level of service and quality, and our ISO 13485 certification is just one way that we demonstrate this commitment. We look forward to partnering with you to bring your innovative medical device ideas to life.


Axxicon’s Validation protocol

To ensure compliance with ISO 13485, we have developed a rigorous validation protocol that is designed to verify and validate our products. Our validation protocol follows the requirements of ISO 13485 and covers all aspects of the product lifecycle, from design and development to manufacturing and distribution. The protocol consists of a series of tests, procedures, and documentation that are designed to provide evidence of conformity with ISO 13485.


The steps of validation are: Design Qualification, Installation Qualification, Operations Qualification, Performance Qualification


Design Qualification (DQ)

In the Design qualification (DQ) we demonstrate that the proposed design will satisfy all requirements which are defined and detailed in the User Requirements Specification (URS). We emphasize all relevant documentation regarding the DQ. A clear instruction of our DQ method will guide our injection molding pathway.


Installation Qualification (IQ)

The IQ protocol verifies that the installation with peripherals has been installed on the basis of installation drawings and/or specifications. Furthermore, it describes in detail a list of cGMP requirements that apply to the installation. These requirements must be met before the IQ can be completed and one can proceed with the Operational Qualification (OQ)


Operations Qualification (OQ)

During the Operations Qualification the process parameters should be challenged to assure that they will result in a product that meets all defined requirements under all anticipated conditions of manufacturing, i.e., worst case testing. During routine production and process control, it is desirable to measure process parameters and/or product characteristics to allow for the adjustment of the manufacturing process at various action level(s) and maintain a state of control. These action levels should be evaluated, established and documented during process validation to determine the robustness of the process and ability to avoid approaching “worst case conditions.”


Performance Qualification (PQ)

Process and product data should be analyzed to determine what the normal range of variation is for the process output. Knowing the normal variation of the output is crucial in determining whether a process is operating in a state of control and is capable of consistently producing the specified output.


One of the outputs of OQ and PQ is the development of attributes for continuous monitoring and maintenance. Process and product data should also be analyzed to identify any variation due to controllable causes. Depending on the nature of the process and its sensitivity, controllable causes of variation may include:

  • Temperature
  • Humidity
  • Variations in electrical supply
  • Vibration
  • Environmental contaminants
  • Purity of process water
  • Light
  • Human factors (training, ergonomic factors, stress, etc.)
  • Variability of materials
  • Wear and tear of equipment


Appropriate measures should be taken to eliminate controllable causes of variation. Eliminating controllable causes of variation will reduce variation in the process output and result in a higher degree of assurance that the output will consistently meet specifications.