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