Abrimed 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 Abrimed 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.