Medical Equipments make up for a very broad arena of products. It comprises many different testing instruments ranging from electrical safety to sophisticated diagnostic X-Ray meters. Medical Devices earlier have never been evaluated as rigorously as they are today. From a regulatory perspective, the ISO 10993 guidelines require assessment of the finished medical devices.
This requirement ensures the appropriate assessment of device biocompatibility, as there can be any number of factors that can alter the outcome of the device during use. Such factors can be chemical exposures, sterilization processes, various manual interactions, packaging, material degradation and other related factors. As the impact of these factors were better understood, the process of Medical Device Testing and data gained further significance.
All medical devices have a unique and thorough set of requirements for testing, which is enforced by many regulatory bodies that need to be fulfilled before the devices are released in the market. Medical Devices are also becoming smaller and more complex in design, mostly using advanced engineered plastics.
This makes the process of Medical Device Testing, their Validation and Verification even more important. Validation and Verification (V&V) is basically a device testing process – Validation ensures that the evidence the user needs and the intended use of the devices are met in actual medical conditions. This process usually involves tests, inspection and analysis. Verification typically confirms the objective evidence that specific requirements are met.