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:

Company’s Keywords:

regulatory affairs, quality assurance, risk management, clinical trials, fda, iso, compliance