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NJK & Associates

NJK & Associates

生物技术研究

San Diego，CA 107 位关注者

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关于我们

NJK & Associates provides hands-on, action-based solutions to your Quality and Regulatory needs. We have extensive experience with a wide range of medical devices and in-vitro diagnostics, including: - Infusion Pumps - Orthopedic Implants, instruments, guidance systems, accessory tables - Spinal Implants - Ocular Implants - Laparoscopic Surgical Instruments - Lateral Flow Diagnostics - Molecular Diagnostics - Genomics Additional Expertise in: - New Product Development - Invention, development, testing, safety certification, manufacturing transfer,... - Project Management - FDA interactions - Submissions from concept to clearance - Internal and Supplier Audits - Due Diligence Audits pre-purchase and pre-acquisition

网站
https://njkconsulting.com
所属行业
生物技术研究
规模
2-10 人
总部
San Diego，CA
类型
私人持股
创立
2006
领域
Quality System Development & Implementation、Regulatory Strategies, Pre-IDE, Submissions、Product Development、Manufacturing Engineering、Gap and Supplier Audits和Root Cause Analysis

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