Fda/Iso Medical Device Regulatory Affairs & Quality Assurance Consulting
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- 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
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Headquarters:Po Box 3900 , Dana Point, California, United States
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Phone Number: +1 949-433-3058
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Employees:7
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Revenue:$1 - 10M
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Legal Name:Fda/Iso Medical Device Regulatory Affairs & Quality Assurance Consulting
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| NAICS Code: 561990 |
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Frequently Asked Questions regarding Fda/Iso Medical Device Regulatory Affairs & Quality Assurance Consulting
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Where are Fda/Iso Medical Device Regulatory Affairs & Quality Assurance Consulting's Headquarters?
Fda/Iso Medical Device Regulatory Affairs & Quality Assurance Consulting's Headquarters are in Po Box 3900 ,Dana Point,California,United States
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What is Fda/Iso Medical Device Regulatory Affairs & Quality Assurance Consulting's phone number?
Fda/Iso Medical Device Regulatory Affairs & Quality Assurance Consulting's phone number is +1 949-433-3058
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What is Fda/Iso Medical Device Regulatory Affairs & Quality Assurance Consulting's Revenue?
Fda/Iso Medical Device Regulatory Affairs & Quality Assurance Consulting's revenue is $1 - 10M
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What is Fda/Iso Medical Device Regulatory Affairs & Quality Assurance Consulting's NAICS code?
Fda/Iso Medical Device Regulatory Affairs & Quality Assurance Consulting's NAICS code is 561990
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How many employees are working in Fda/Iso Medical Device Regulatory Affairs & Quality Assurance Consulting
Fda/Iso Medical Device Regulatory Affairs & Quality Assurance Consulting has 7 employees
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What is Fda/Iso Medical Device Regulatory Affairs & Quality Assurance Consulting's Industry?
Fda/Iso Medical Device Regulatory Affairs & Quality Assurance Consulting is in the industry of Medical Devices
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Who is Fda/Iso Medical Device Regulatory Affairs & Quality Assurance Consulting's Lead Reviewer?
Fda/Iso Medical Device Regulatory Affairs & Quality Assurance Consulting's Lead Reviewer is David Fadae