About Li-Med

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Li-Med – Regulatory and QA Experts

Founded in 2007. Li-Med provides domestic and international regulation administration as well as quality assurance services. By implementing its expertise and understanding of QA & RA system requirements, Li-Med has been successful in assisting medical companies pass the FDA, CE, and other application processes.

Li-Med’s trusted and proven expertise

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 Systems according to ISO13485 and 21CFR part 820

Outline Regulatory Strategy (FDA, CE) and Manage Regulatory activities

Formulate Design Dossier / Technical File (TF) for Submission

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