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
