It is imperative to engage a testing company with expertise in regulatory compliance and contamination control to ensure the safety and efficacy of your medical devices and cleaning and disinfection processes. Element reusable medical device reprocessing validation services help you ensure the safety of your staff and your patients.
Reusable Medical Device Tests (GLP Compliant)
Every reusable medical device must be reprocessed before reuse to ensure risk of contamination is minimized; this includes cleaning and either sterilization or disinfection. Before any device can be brought to market, the process for each of these must be validated to prove efficacy. Whether validating Instructions for Use (IFU) already developed or helping to create new IFU with our guidance, our experts will develop a separate testing protocol for each processing category applicable.
In cases where reprocessing parameters are not ready for validation, we’ve got the experience and knowledge to test parameters in a non-regulatory, R&D setting and finalize reprocessing instructions ready for the validation phase.
If you'd like to learn more about our reprocessing validation services, contact us today.
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Reusable Medical Device Validation
Our medical device experts evaluate the environmental impact on the identification markings and function of reusable medical instruments after repeated autoclave sterilization cycles.
Medical Device Regulatory Services
Our medical device regulatory experts help manufacturers of medical devices with product registrations, quality management systems, and in-country and global approvals.
As a comprehensive testing partner, you’ll enjoy the benefit of a single supplier source for all of your testing needs, from mechanical testing and environmental simulation to EMC and wireless device testing.
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