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)

• California Department of Health Services (CDHS)
• CDHS Food and Drug Branch and Division of Food, Drug and Radiation Safety
• California Office of Administrative Law (OAL)
• California department of Food and Agriculture (CDFA)
• California Institute for Regenerative Medicine (CIRM)
• Medical Board of California (MBC)

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