JB & Associates

JB & Associates provides FDA consulting services for the healthcare industry. Our team of experts includes regulatory affairs professionals, product design/engineering firms and other regulatory professionals. We focus on medical product development and manufacturing, from concept through testing, clinical trials, FDA/ISO regulatory compliance and ongoing manufacturing. Contact JB & Associates Regulatory Consultants for…. Authorized Representatives, US Agents and Official Correspondents with the FDA ISO and FDA regulatory affairs professionals ISO 13485 and ISO 9001 registration and certification consultants Medical device development and manufacturing engineers EU CE Mark Medical Device Directive (MDD, IVDD and AIMDD) consultants FDA GMP regulations, QSR and product validation specialists FDA and ISO audit advisors Quality systems and quality assurance (QA/QC) consulting experts FDA 510k notification/submissions specialists Medical product lab testing, IEC and clinical trials consultancy Medical, pharma and biotech company international distribution and support Abrimed is based in Southern California, with experience throughout North America, Europe and Asia/China. Based in California, we assist domestic firms throughout the US, as well as international clients mainly in Europe and Asia (China). We work with government agencies, public and private research institutes, laboratories and industry. Learn more by exploring the following links, or Contact Us to discuss your specific needs: