With extensive knowledge of the commercialization processes, regulatory requirements and scientific trends in the Medical Device Industry, our scientists and engineers have been assisting companies, large and small, with developmental testing and regulatory submissions since three decades.

Our 16 state-of-the-art facilities throughout North America, Europe and Asia Pacific offer extensive capacities and the highest level of instrument technology, enabling us to provide the full scope of testing services required by the Medical Device Industry.

Eurofins Medical Device Testing can help to develop and execute your test plans and navigate the regulatory pathway to market anywhere in the world. Our laboratories maintain quality systems compliant with cGMP, GLP and ISO 17025, and conducts testing in accordance with ISO, ASTM, ANSI, AAMI, USP, EP and JP standards, as well as custom test methodologies to meet the unique needs of our customers.

In our laboratories in Munich we are offering in vitro safety testing for Medical Devices according to ISO 10993, ISO 7405, ISO 11979-5 and others.

With our partner BSL BIOSERVICE we complete our service spectrum in Munich, offering in vivo safety and activity testing services for your device.

Our colleagues from Eurofins Consulting support you additionally from the very beginning throughout the complete development of your product. The experts provide you with expert statements, conduct risk assessments as well as gap analysis and support you with the planning of your test strategy.

Eurofins Cyber Security is a new member of the Eurofins Group in Germany, offering a comprehensive range of security services to ensure medical devices meet the highest standards for security.

With the highest level of instrument technology available in the industry, Eurofins Medical Device Testing utilizes the most state-of-the-art instrumentation to deliver accurate and timely test results, including:

Analytical Chemistry: Our chemistry laboratories are equipped with nearly 400 HPLCs and 100 GCs with more than 600 detectors to characterize the chemical constituents of materials used throughout the development process.

Microbiology: With more than 6,300 m² (68,000 ft2) of microbiology lab space worldwide, we offer a full range of standard microbiology services, including six clean room suites for validations of terminal sterilization, as well as for reprocessing of reusable devices and environmental monitoring to support your clean manufacturing facilities.

Biocompatibility: We offer a variety of cell-based alternative in vitro methods, including standard tests and tailor-made studies, under GLP, GMP and ISO 17025 to examine the hazardous effects of medical devices. In addition, our partner labs in the US and Europe support in vivo testing in AAALAC-accredited vivariums with 60 animal rooms and dedicated supporting laboratory space, including necropsy rooms, surgical rooms, isolated cage wash areas and various sample preparation and procedure rooms, totaling 2,929 m² (31,500 ft2).

Package Testing: Our new, state-of-the-art package testing facility is equipped to perform functional testing, material testing and aging/stability of primary, secondary and shipping configurations. Our engineers will help you evaluate every aspect of your packaging from sterile seal integrity through distribution and transit testing of full pallet-sized loads, and durability of your labels. We also have a wide range of material property testing equipment to ensure packaging materials perform consistently before and after sterilization.

Shelf-Life & Product Stability Testing: With more than 5,300 m3 (187,000 ft3) of stability space worldwide and a wide range of environmental chambers meeting ASTM/ISO/ICH conditions, we have the largest global capacity for accelerated and real-time stability and aging studies.

Medical Device Testing is a service offered by Eurofins BioPharma Product Testing Munich GmbH. The Company has been established in 1995 and has its premises in Planegg near Munich. Including further laboratories Hamburg, Homburg and Constance the total laboratory and office space of the Eurofins BioPharma Product Testing Group in Germany amounts to more than 20,000 sqm with more than 700 employees.