NJK & Associates

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

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