Zi-Medical, Inc.

medical devices

About

Zi Medical provides services to assist the international medical device companies globally with China, US, EU as primary markets.. We provide one stop service to companies including regulatory strategy, submissions, quality management systems, regulatory authority engagement (meetings/enforcement action). Services we provide: -Regulatory Services * Regulatory Strategy for One or Multiple Markets * International Product New Registrations and License Renewal * Pre-submission Consultations and Fillings * GMP/QSD Registrations * Regulatory Management Development * Quality Compliance * Regulatory Staff Training * Chinese & Taiwanese Regulatory Guidance English Translations * Chinese & Taiwanese Testing Standards English Translations -Marketing Services * Business Strategy for Urgent Market * Marketing Research and Development * Distributor/ Partner Search * Continuing Process Improvement Regions we cover: China, Taiwan, Hong Kong, Singapore, Japan, Korea, Malaysia, Philippines, Singapore, Indonesia, India, Thailand, Vietnam, New Zealand, Australia, etc..

Technologies

Gmail Google Apps Render Android

Keywords

regulatory strategy medical devices gmp registration product license renewal & change notification 510k 513g pma establishment registration hipaa gdpr ivd regulatory technology samd premarket clearance compliance registered agent quality audit prep registration submission strategy regulatory affairs outsourcing operational excellence process improvement submission management systems quality system selection hospital & health care

Location

Cambridge, Massachusetts, United States, 02141

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