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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...
Support companies from zero to launch,direct companies in all the development and validation phases,establish biocompatibility plans according to iso 10993 standards,implement quality system according to iso13485 and 21cfr part 820,outline regulatory strategy (fda,ce) & manage regulatory activities,formulate design dossier / technical file (tf) for submission,complement the regulatory process with the appropriate laboratory services,and bio testing
Eurofins | li-med operates in the Medical and diagnostic laboratories industry.
Eurofins | li-med's revenue is 11m - 100m
Eurofins | li-med has 11 - 50 employees.
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