California-CA

State (California…)

FDA, ISO Regulatory Affairs in California

FDA and ISO Regulatory Affairs Consultants in California:  FDA and ISO medical device consultants serving Southern/Northern California.

Relevant State Agencies

California State Agencies (Sacramento, CA)

Services

Medical Business Startup

  • Business Plan, Funding (Seed Capital)
  • R&D, Prototypes, Design Validation and Design Controls
  • Manufacturing
  • Strategic Planning, Marketing and Distribution

FDA 510K Notifications

  • Traditional 510(k)
  • Special 510 (k)
  • Abbreviated 510(k)

State Regulations

  • State Regulatory Guidelines and Requirements (CA, WA, OR, AZ, NY, NJ, FL…)
  • Local government regulations in Northern California (San Jose and San Francisco) and Southern California (San Diego, Orange County and Los Angeles-LA)

NDA New Drug Applications
PMA Pre-market Approvals (Class III)

Quality Systems

  • ISO Quality Systems Implementation, Certification and Registration Consulting
  • ISO 13485, ISO 9001, ISO 13488:2000
  • CE Marking and EU Medical Device Directives Compliance (MDD, IVDD, AIMDD)
  • Audit preparation, documentation, training…

Supplements and Alternative Medicine

  • Applied Nutrition
  • Botanical Drugs
  • Dietary Supplements
  • Importing from Asia

Laboratory Compliance Testing

  • FDA, UL and CSA
  • CE and EU MDD
  • IEC 60601-1 and 61000-1 (EMC), ETL, EMI
  • Biocompatibility and Toxicity
  • Clinical Trials

Risk Management

  • Risk Assessment, Hazards Analysis, FMEA, FTA, HFE…
  • FDA Guidelines
  • ISO 14971

International Regulations

  • Import/Export Permits
  • Europe/Asia Product FDA approvals for US Market
  • FDA Authorized Representative and US Agent
  • Global Distribution (Canada, Germany, UK, France, China, Japan, India…)
  • US Medical Products Asian and EU Approvals

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