How Do We Apply V&V Testing in the Medical
In terms of medical device molding in Seaskymedical, the injection molding testing is a crucial step before the production of medical device. There are many different tests to be applied, such as wall thickness, cavity strength and small batch testing. But the most important point is the impact on the overall quality of medical device.
FDA Software Validation
In the FDA software validation process, the company will find out the software used in the medical plastic injection modling device. It would be useful to find out the software used in medical device before the medical device is made. Validation and verification medical device will greatly help to ensure the accuracy and quality work of a medical molding company.
Thermal Analysis of an Assembly
In Seaskymedical, the thermal analysis of an assembly is a method of testing the device or the parts. Different thermal analysis tools will be used in the testing of the device, such as infrared thermal analyzers, infrared radiometers, or differential scanning calorimetry.
Fault Tree Analysis of a Process or Design
The fault tree analysis of a process or design will be tested in Seaskymedical to ensure the process or design’s accuracy. The results of the fault tree analysis will be used to assess the process’s effectiveness.
Failure Modes and Effects Analysis
We will perform the failure modes and effects analysis as a method of evaluating the effect of the device on the human body. The failure modes and effects will be analyzed so that the device can be adjusted to meet the needs of the user.
Package Integrity Tests
Seaskymedical’s package integrity tests are based on the device’s internal and external factors. After the device is manufactured, the package integrity tests will be adjusted to ensure the package’s integrity.
Biocompatibility Testing of Materials
Biocompatibility testing of materials is a method used by Seaskymedical to ensure the safety of the materials on humans. Biocompatibility tests, for example, can be performed on any type of material that will be used in the medical device. The medical device’s materials will also be tested.
Bioburden Testing of Products to Be Sterilized
The bioburden testing of products in sterilization validation for medical devices at Seaskymedical is a test to evaluate the safety of the materials or devices. Materials testing can be done on products such as medical equipment, medical devices, or medical supplies.