Reusable Medical Device Validation Services

For a reusable medical product to achieve the desired results for doctors and patients, it needs to undergo several rounds of thorough testing. From how users clean your device to its packaging systems and overall expected shelf life, each aspect of your product greatly impacts its effectiveness and safety. Therefore, it’s crucial that you have a team of professionals who can ensure everything performs as it should.

HIGHPOWER Validation Testing & Lab Services has been validating reusable medical devices for over 30 years. With an experienced staff, a modern facility and an outstanding reputation for customer service, we provide a wide range of medical device validation, device testing and sterilization services to OEM’s around the world. With a myriad of both high and low temperature sterilization, let HIGHPOWER assist you in bringing your device to market. Here’s what you need to know about our series of reusable medical device validation services.

Cleaning Validation

When it comes to patient safety it is necessary to prove that your device can be properly cleaned with gross amounts of soil removed between uses. This type of medical device validation tests the effectiveness of your product’s cleaning guidelines, allowing you to better understand whether it will be a good fit for a real-life hospital environment. Our range of tests can measure the effectiveness of different cleaning processes, such as automated and manual. We also have several different analytes we are able to measure based on your specific test requests.

Packaging Systems and Shelf Life

Our packaging system testing ensures that the packaging system of choice for sterilization of your device (pouches, rigid containers, sterilization wrap) maintains the sterile barrier after processing and measures that your device is still sterile after certain shelf life time intervals. We have several high- and low-temperature sterilization tests for this, and we work hard to simulate a real hospital environment.

Sterilization Efficacy

Medical devices need a method of sterilization or disinfection to be defined by the manufacturer prior to patient use. Sterilization is the process of removingg all harmful microorganisms from your product following a sterilization cycle. HIGHPOWER has access to all FDA cleared sterilization processes in the industry. With our high- and low-temperature sterilization testing offered inhouse, we can cover a wide range of scenarios and ensure your product meets all regulatory requirements for patient safety.

Reusable medical device validation services are a vital part of producing a quality product for the health-care industry. Validation in your process design will ensure that your device is up to par with the industry standards before it hits the market. We’ve detailed only a few of HIGHPOWER’s validation and testing options above, and we have several more services available based on what stage of development you’re in. Contact us today at clientservices@highpowervtls.com with your inquiry, and we’ll help you determine the best course of action for your needs.