FDA 510k Notifications (Class II)
FDA 510K Notifications (Class II Medical Devices)
• Traditional 510(k)
• Special 510 (k)
• Abbreviated 510(k)
• Special 510 (k)
• Abbreviated 510(k)
FDA PMA Premarket Approvals (Class III Medical Devices) and
NDA New Drug Applications
• PMA Premarket Approvals for Class III Medical Devices
• PMA Supplements and PMA Amendments
• IDE Investigational Device Exemptions
• PMA Supplements and PMA Amendments
• IDE Investigational Device Exemptions
Quality Systems Implementation, ISO Certification, GMP, EU MDD and CE Marking
• 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…
• ISO Quality Systems Implementation, Certification and Registration Consulting
• CE Marking and EU Medical Device Directives Compliance (MDD, IVDD, AIMDD)
• Audit preparation, documentation, QMS training…
Dietary Supplements, Alternative Medicine FDA Approvals in US
• Applied Nutrition and Dietary Supplements
• Botanical Drugs
• Importing from Asia (Traditional and Herbal Medicine)
• NDA New Drug Approvals
• Botanical Drugs
• Importing from Asia (Traditional and Herbal Medicine)
• NDA New Drug Approvals
Laboratory Compliance Testing, Animal and Human Clinical Trials
• 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 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
Risk Management
• FDA Risk Management Guidelines
• ISO 14971
• Risk Assessment, Hazards Analysis, FMEA, FTA, HFE…
• ISO 14971
• Risk Assessment, Hazards Analysis, FMEA, FTA, HFE…
International Regulations, Approvals and Permits
• 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
• 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 Regulations (California, etc)
• 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)
• 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)
Medical Business Start-up Services – Funding, Business Plans, Prototypes
• Business Plan, Funding (Seed Capital)
• R&D, Prototypes, Design Validation and Design Controls
• Clinical Trials and Testing
• Manufacturing, Quality Systems
• Strategic Planning, Marketing and Distribution, US/International Regulations
• R&D, Prototypes, Design Validation and Design Controls
• Clinical Trials and Testing
• Manufacturing, Quality Systems
• Strategic Planning, Marketing and Distribution, US/International Regulations
