FDA 510k Notifications (Class II)

 FDA 510K Notifications (Class II Medical Devices)

 Traditional 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

 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…

 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

 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

 Risk Management

 FDA Risk Management Guidelines
 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

 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)

 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


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