NJK & Associates

NJK & Associates is a private medical device quality assurance and regulatory affairs consultancy based in San Diego, California. The firm supports medical device and in vitro diagnostic companies with quality system design and administration, audit remediation, complaint handling, eMDR reporting, regulatory strategy, pre-submissions, and 510(k) and international submissions. Its work appears focused on helping clients develop, remediate, and commercialize regulated products rather than advancing an internal therapeutic pipeline. The company highlights experience across infusion pumps, orthopedic implants, spinal implants, ocular implants, laparoscopic instruments, lateral flow diagnostics, molecular diagnostics, and genomics-related products. NJK & Associates is therefore healthcare-related, but it is not a biotech or pharma drug developer.