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Two female scientists in a laboratory wearing safety goggles and lab coats, working with pipettes and medical devices. The image is related to medical device services, emphasizing precision and expertise in a clinical or research setting

Precision. Proficiency. Proximity.

We assist companies with the development and life cycle management of their medical devices, through our global network of regulatory experts, 20+ laboratories, and 2 sterile packaging sites in Europe, North America, & Asia Pacific. Companies of all sizes benefit from our 40+ years of expertise and capabilities to ready their products for market launch and post-marketing activities through three independent services: consulting, testing, and sterile packaging.

Our extensive experience in commercialisation processes, regulatory requirements, and industry trends ensures rapid turnaround of your project with the highest level of service and most advanced technologies.

Our Services

Consulting

Testing

Sterile Packaging

Number of Projects every year

1710

Consulting

23000

Biocompatibility

580

Sterile packaging

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.

Medical Device Consulting

The partner you can trust to manage the lifecycle of your medical device.

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 12.200 m3 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.

Eurofins Medical Device Sterile Packaging: Safe. Sterile. Packing.

From the raw compounds to the medical device, ready-for-sale – we ensure highest quality at utmost safety. 100% service from one source: That’s what inpac Medizintechnik has proven for 15 years. We’ll find your solution. Custom-made, fast, economical. Simply competent.

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.

Eurofins Medical Device Service Sterile Packaging

We package your products! Innovative, sterile, legally valid – including the necessary steps for you towards MDR-Compliant Certification.

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.

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