MK
Mordehai Koskas
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Work Experience
Company Details
11-50 Employees
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
Year Founded
2007
Social Media
Linkedin
Industry
Medical and Diagnostic Laboratories
HQ Location
24 Imber st Kiryat Arie Petach Tikva, Israel 4951158 , IL
Keywords
Support companies from Zero to LaunchDirect companies in all the development and validation phasesEstablish biocompatibility plans according to ISO 10993 standardsImplement Quality System according to ISO13485 and 21CFR part 820Outline Regulatory Strategy (FDACE) & Manage Regulatory activitiesFormulate Design Dossier / Technical File (TF) for SubmissionComplement the regulatory process with the appropriate laboratory servicesand bio testingFormulate Design Dossier / Technical File (TF) for Submissio
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