Specialist Services

For Medical devices and Inhalation testing, Eurofins Medical Device Testing is your “one stop” shop partner. With >20 laboratories in North America, Europe and Asia Pacific, our specialist services offer regulatory compliance expertise and experienced GMP/GLP/ISO 17025 testing to ensure rapid turnaround times with the highest level of service, and most advanced technologies for your analytical chemical, microbiological, biocompatibility, electrical, mechanical and package testing needs

From implants and instruments, to single-use and combination products, as well as active electronic devices, Eurofins Medical Device Testing provides the optimal testing strategy for all types of class I, II and III medical devices and are dedicated to helping you verify and validate your product designs; confirm safety and efficacy; and ensure user needs are met.

With extensive knowledge of the commercialisation process, international regulatory requirements, and scientific trends, our scientists and engineers have been assisting companies, large and small, with developmental testing and regulatory submissions for more than 40 years.

Our >20 state-of-the-art facilities throughout North America, Europe and Asia Pacific offer extensive capacity and the highest level of instrument technology, enabling us to provide the full scope of testing services required by the Medical Device Industry, with rapid turnaround times and unsurpassed customer service.

With an unwavering commitment to global regulatory standards, Eurofins Medical Device Testing can help develop and execute your test plans, and navigate the regulatory pathway to market anywhere in the world. We maintain quality systems compliant with cGMP, GLP and ISO 17025, and conduct testing in accordance with ISO, ASTM, ANSI, AAMI standards, as well as custom test methodologies to meet our customers’ unique challenges.

These three simple words comprise the most important elements of our Medical Device testing.

Precision – Accuracy in testing is paramount to ensuring product safety and efficacy. And fast turnaround times are critical to keeping your project on schedule.With the highest level of instrument technology available in the industry, Eurofins Medical Device Testing utilises the most state-of-the-art instrumentation to deliver accurate and timely test results.

Proficiency – Thorough testing of your medical device and/or component can help to identify unforeseen challenges early in the development process, and ultimately avoid costly delays. With more than 100 PhDs worldwide, you can rely on our extensive knowledge of the commercialisation process, regulatory requirements and scientific trends in the Medical Device industry to keep your product moving smoothly through the development pipeline.

Proximity – Partnering with the right laboratory to troubleshoot your product challenges fosters the ability to obtain global market approval. With testing and regulatory expertise across >20 facilities in North America, Europe and Asia Pacific, Eurofins Medical Device Testing effectively meets your testing needs from virtually anywhere in the world.

Performing product testing on drugs, which are delivered via oral inhalation or nasal routes, can be especially challenging given the complex drug-device combination relationship and the advanced techniques which are required. It takes not only the right equipment but also the right analytical team to ensure success.

Eurofins BioPharma Product Testing has supported the development of inhalation products for more than 15 years from early phase development through commercialization. Our highly skilled staff have decades of experience testing a wide range of drug-device combination inhalation products. So whether you are developing a pMDI, an inhaled biologic or a nebulized formulation Eurofins BioPharma Product Testing can provide the solution you need.

• We have in-depth experience working with a wide range of drug/device delivery systems.
• We work with you to design the program to meet your company’s specific needs and expectations
• Coupled with our Extractables/Leachables experience, Eurofins BioPharma Product Testing can provide expanded coverage to your inhalation testing and analytical needs.

• Pressurized Metered Dose Inhalers (pMDI)
• Dry Powder Inhalers (DPI)
• Nebulizers (UDV & MDV)
• Aqueous Nasal Sprays