JKS & Associates

Contact: John Suzuki
Year Established: 1993
No. of Employees: 2
Key Clients: Pfizer, Integ, Ohmeda, Liebert (Emerson Electric), Xerox, IBM Global Services, AMO, Cordis, Alcon. JKS & Associates provides cost-effective software consulting for small and large manufacturers in requirements analysis, design, verification and validation, ISO 14971, 21 CFR Part 11, ISO 9000-3 software certification and auditing, software testing, SEI software capability evaluation, software process improvement, cybersecurity, and FDA GMPs. The company’s core competencies include computer-controlled devices and manufacturing processes and FDA software PMA and 510ks submissions.