Eurofins | Li-Med

About

Eurofins Li-Med has been working with both domestic and international
customers to formulate and execute successful regulatory activities and quality assurance, exclusively serving the medical device industry. Our dedicated
experts are focused on producing the most meaningful, comprehensive, and
submission-ready compilation of non-clinical data, to ensure compliance with
regulation and approval for marketing and clinical trials. As global regulatory
requirements keep evolving, our experts are fully updated in all changes and are
in constant contact with notified bodies representatives and competent authorities
to pave the appropriate path to market success. On top of that we support our
clients in their endeavors to provide evidence that meets regulatory standards
by liaising with several prominent laboratories.
Expertise

Keywords

support companies from zero to launch, direct companies in all the development & validation phases, establish biocompatibility plans according to iso 10993 standards, implement quality system according to iso13485 & 21cfr part 820, outline regulatory strategy fda, ce, manage regulatory activities, formulate design dossier, technical file for submission, complement the regulatory process with the appropriate laboratory services, bio testing

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