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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
Quality system development & implementation,regulatory strategies,pre-ide,submissions,product development,manufacturing engineering,gap and supplier audits,and root cause analysis
Njk & associates operates in the Biotechnology research industry.
Njk & associates's revenue is 11m - 100m
Njk & associates has 11 - 50 employees.
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