Regulatory compliance
Qualified investigators and sites
Expertise and experience
Clinical trial management
In-house facilities
Have in-house clinical trial facilities with expertise in medical device investigations, ensuring seamless execution of clinical trials
Ensuring the safety and compliance of cosmetic medical devices is a complex challenge due to stringent regulatory requirements and the need for rigorous testing
Eurofins offers specialized testing services that guarantee compliance with industry regulations, enhance product safety, and support innovation. Our expertise helps you navigate the complexities of medical device testing, ensuring your products meet the highest standards.
Eurofins operates over 20 state-of-the-art medical device testing facilities across North America, Europe, and Asia Pacific. This extensive network ensures rapid turnaround times and access to a diverse pool of clinical trial participants, facilitating efficient and globally compliant clinical investigations.
With more than 40 years of experience, Eurofins provides in-depth knowledge of international regulatory requirements. Their laboratories maintain quality systems compliant with cGMP, GLP, and ISO 17025, conducting testing in accordance with ISO, ASTM, ANSI, AAMI standards, as well as custom test methodologies tailored to meet unique customer needs.
Eurofins offers a full spectrum of testing services, including biocompatibility, microbiology, analytical chemistry, electrical and mechanical testing, packaging validation, and stability studies. This comprehensive approach supports the entire lifecycle of medical device development, from preclinical testing to regulatory submission.