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Testing

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Advanced solutions ensure the safety, efficacy, and quality compliance of your devices.

We provide GMP/GLP/ISO 17025/ASCA testing to provide rapid turnaround times with the highest level of service. We utilise the most advanced technologies to meet your chemical, microbiological, biocompatibility, mechanical and packaging testing needs. Our capabilities encompass the entire ISO 10993 series, Extractables and Leachables, material and product stability, ethylene oxide (EO) residuals testing, & combination product testing, to name a few.

Medical Device Testing

Advanced solutions ensure the safety, efficacy, and quality compliance of your devices.

Maintain Sterile Barrier Integrity with Eurofins

Sterile Barrier Integrity Testing is critical throughout the course of distribution and storage for all terminally sterilised medical devices. Let Eurofins Medical Device Testing determine the most appropriate testing method based on your device and/or packaging configurations to ensure device integrity per ISO 11607, ASTM F1929 or ASTM F2096. Watch the video to learn more.

Your Global Package Testing Partner

Eurofins Medical Device Testing’s state-of-the-art Package Testing Lab is GMP, ISTA certified and ISO 17025 accredited to help evaluate every aspect of your packaging and labeling configurations. Our experts help perform functional testing, material testing, and accelerated and/or real time aging studies of primary and secondary packaging configurations to ensure your product will survive the rigors of global transit. Watch this video to learn more about our complete capabilities.

Ensure Your Device Survives Global Transport

No matter how or where your device is shipped, it is important to ensure your product will survive the rigors of global transit. Our state-of-the-art laboratory testing very precisely simulates various standard and custom distribution cycles per ISO 11607 and ASTM D4169, for the environmental conditions your packaging will encounter during transit. As you finalize your packaging designs, and prepare to conduct your validation work, our team of engineers is ready to work with you to ensure your product gets to its destination in the same condition it leaves your facility.

Verify the Shelf Life of Your Device

Any medical device brought to market must have an expiration date, backed by shelf life testing. Eurofins Medical Device Testing’s shelf life and accelerated aging testing services ensure your device meets its intended use just as effectively after years of storage as the day it was manufactured. With more than 200,000 ft3 of storage space, and a wide range of environmental chambers for predefined and custom conditions, our state-of-the-art labs support all aspects of your aging studies. Watch the video to learn more about our complete capabilities.

Chemical/Physical Analysis

Microbiology & Sterility Testing

Biocompatibility Testing

Packaging Testing

Viral Safety

Combination Products

Human Factors

Electrical Medical Equipment

Clinical Trials

Materials & Chemical Characterisation
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