NJK & Associates

About 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

Website	http://njkconsulting.com
Employees	11-50 employees View all NJK & Associates employees
Industry	Biotechnology
Location	San Diego,San Diego,CA,US
Founded	2006
Keywords	Product Development, Root Cause Analysis, Manufacturing Engineering, Submissions, Pre-Ide, Regulatory Strategies, Gap And Supplier Audits, Quality System Development & Implementation