Medical Device Clinical Investigations
Expert medical device testing support
Regulatory compliance
Ensure clinical studies meet EU MDR 2017/745 and ISO 14155:2020 standards, ensuring high quality and patient safety.
Qualified investigators and sites
We maintain a database of qualified investigators and sites, including key opinion leaders, to ensure robust and reliable clinical data.
Expertise and experience
With 40+ years’ experience, Eurofins C&PC has 8 research centers acting as CRO and CRC to support various stages of clinical investigations.
Clinical trial management
We offer full-service support: project management, regulatory submissions, data and stats management, and expert medical writing.
In-house facilities
Benefit from in-house clinical trial facilities with expertise in medical device investigations, ensuring seamless execution of clinical trials.
Expert testing for safe, innovative medical devices
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 C&PC 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.
What sets Eurofins C&PC apart?
Comprehensive global network
Eurofins C&PC 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.
Expertise in regulatory compliance
With more than 40 years of experience, Eurofins C&PC 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.
Comprehensive testing services
Eurofins C&PC 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.
