FDA/ISO Regulatory Affairs Consultants 
      AREAS OF EXPERTISE
SERVICES
• Traditional 510(k)
• Special 510 (k) • Abbreviated 510(k)
• PMA Premarket Approvals for Class III Medical Devices
• PMA Supplements and PMA Amendments • IDE Investigational Device Exemptions
• ISO 13485, ISO 9001, ISO 13488:2000
• ISO Quality Systems Implementation, Certification and Registration Consulting • CE Marking and EU Medical Device Directives Compliance (MDD, IVDD, AIMDD) • Audit preparation, documentation, QMS training...
• Applied Nutrition and Dietary Supplements
• Botanical Drugs • Importing from Asia (Traditional and Herbal Medicine) • NDA New Drug Approvals
• Laboratory Testing
• FDA Compliance • UL and CSA • CE and EU MDD • IEC 60601-1 and 61000-1 (EMC), ETL, EMI • Biocompatibility, Toxicity, Sterilization Validation ... • Animal and Human Clinical Trials
• FDA Risk Management Guidelines
• ISO 14971 • Risk Assessment, Hazards Analysis, FMEA, FTA, HFE...
• Import/Export Permits
• US Medical Products Asian and EU Approvals • Europe/Asia Product FDA approvals for US Market • FDA Authorized Representative and US Agent • Global Distribution (Canada, Germany, UK, France, China, Japan, India ...) • International Regulation Consultants
• State Regulatory Guidelines and Requirements (CA, WA, OR, AZ, NY, NJ, FL…)
• State Departments of Health • Local government regulations in Northern California (San Jose and San Francisco) and Southern California (San Diego, Orange County and Los Angeles-LA)
• Business Plan, Funding (Seed Capital)
Directory
• R&D, Prototypes, Design Validation and Design Controls • Clinical Trials and Testing • Manufacturing, Quality Systems • Strategic Planning, Marketing and Distribution, US/International Regulations |
|
|