Medical Testing Products

Posted by Admin | 29 Mar

Across the globe, people depend on a wide range of medical devices to maintain and improve their health. From pacemakers to insulin pumps to defibrillators, these devices make it possible for healthcare practitioners to collect and analyze stats on a patient’s condition, and make accurate decisions about treatment.

But these devices also need to be safe, effective and fit for practical use. This is why a comprehensive and thorough test is conducted before a device is channeled for use.

A variety of tests are done for medical devices, including materials, functional, electrical, and interoperability testing. These tests ensure that a medical device performs according to specifications and does not provide any information that is inaccurate or misleading.

Material Testing

A wide array of materials is used in medical devices, including metals, plastics, films, resins, and textiles. Various tensile tests are done on these materials to determine their strength, durability and friction properties.

Surgical Tubes

Various shapes and sizes of tubes are used in a number of medical applications, such as drainage, injection or liquid delivery. They can be hollow or shaped, and come in various sizes, connectors and accessories. Surgical tubes are often tested to determine their mechanical properties, such as their strength and durability.

Microprocessor Evaluation

Microprocessors are at the heart of most class II and III medical devices, which means they need to be tested for their electronic performance. Our team can evaluate the microprocessors using a variety of tests that assess logic gate functions and how they're connected.

Sterility Tests and Validation

Sterility tests are a must for all medical devices, as they assess the sterility of a product before it can be transferred to another user or re-used. These tests include direct transfer sterility, product flush sterility, USP sterility testing and more.

Cleaning, Disinfection and Sterilization

Nelson Laboratories offers a full suite of cleaning, disinfection and sterilization validation services to support manufacturers’ reusable medical devices. These include raw material screening, water system testing and residual manufacturing materials, as well as sterility testing to validate a device’s ability to survive a reprocessing process or maintain its sterile characteristics during reuse.

Bioburden Testing and Surveillance

In addition to a sterility test, medical devices need to be evaluated for the presence of viable microorganisms before being disinfected. These tests include bioburden testing to measure the presence of bacteria, yeast and molds that can cause illness and spread infection.

Compliance Testing and Inspections

Manufacturers of medical devices need to be compliant with a variety of federal and regulatory requirements. These include the FDA’s requirements, as well as standards from international organizations like ISO and AAMI.

With our compliance expertise, you can rest assured your medical device meets all necessary testing and certification standards. Whether you’re launching a new product or modifying an existing one, we can help get your device to market quickly and cost-effectively.

Time to Market is key for emerging medical device manufacturers. With a partner who can navigate all compliance requirements, you can reach your target markets quickly and efficiently.

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