FGK Clinical Research GmbH

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Eurofins Medical Device Testing

Behringstrasse 6–8 82152 Planegg/Munich Bavaria Judith Riedelsheimer +49-89-899-650-0 +49-89-899-650-11 mdsales@eurofins.com www.eurofins.com/medical-devices ca. 380 1984

Medical Device Testing

Member of

Comprehensive testing services for medical devices

From implants and instruments to single-use and combination products, as well as active electronic devices, Eurofins Medical Device Testing provides the optimal strategy for all types of medical devices and delivers rapid turnaround times with the highest level of service and most advanced technologies. With extensive knowledge of the commercialisation 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 for three decades. Our 20+ 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 conduct 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.

Chemical/Physical Analysis › Extractables & Leachables › Material & Product Stability › Dissolution › Raw Materials Purity › Particle Characterisation › Residual Ethylene Oxide

Microbiology & Sterility › Sterility / Sterility Validations › Bioburden / Bioburden Validations › Endotoxins / Endotoxin Validations › Antimicrobials / Infection Control › Cleaning & Reprocessing Validations › Bacterial Identification › Customised Test Designs

EUROFINS MEDICAL DEVICE TESTING

Packaging Validation & Seal Integrity › Container Closure Integrity Tests › Sterile Barrier › Package & Transit Testing › Shelf Life & Accelerated Aging / Real Time Aging › Label Durability

Biocompatibility Testing › Cytotoxicity › Hemocompatibility › Genotoxicity › Irritation › Sensitisation › Systemic Toxicity › Implantation (standard, customised, functional) › Degradation Studies

Chemical Characterisation › GCMS +/- Headspace, ICP, LCMS, FTIR › Toxicological Risk Assessment › Expert Evaluation › Inclusion of AET

Combination Products › Drug Release and Dissolution › Chemical Compatibility › Stability › Container & Closure Integrity › Syringe Testing

Mechanical Implant Testing › Material Tests, i.e. Physical Testing (Compression,

Tension, Shear) › Characterisation of Coatings › Particle Analysis and Ion Release Tests › Corrosion Testing › Finite Element Analysis

Notified Body Services › CE Certification

Training & Consulting › Expert Statements and Risk Evaluation › Seminars, Webinars, Trainings