Giuseppa Biasi's Contact Details

Giuseppa Biasi's Company Details

JB & Associates

Oceanside, California, United States • 52 Employees
Medical Devices

JB & Associates provides FDA consulting services for the healthcare industry. Our team of experts includes regulatory affairs professionals, product design/engineering firms and other regulatory professionals. We focus on medical product development and manufacturing, from concept through testing, clinical trials, FDA/ISO regulatory compliance and ongoing manufacturing.FDA 510K NOTIFICATIONS (CLASS II MEDICAL DEVICES) 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