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
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https://njkconsulting.com
NJK & Associates的外部链接
- 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
地点
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主要
San Diego
US,CA,San Diego