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5.2 Medical Device-Related Terminology - Part 2
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Biomedical equipment technician
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Chief medical informatics officer
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Clinical engineering
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Computer-aided diagnosis
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Computer-aided simple triage
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Health technology
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Health technology assessment
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In silico medicine
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Medical device connectivity
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Medical image computing
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Medical technology assessment
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Telemedicine
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3D bioprinting
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3D printing
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Bioburden testing
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Biomedical engineering
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Direct metal laser sintering
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Electron beam additive manufacturing
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Lattice structure
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Medical device manufacturing
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Medical logistics
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Metallic microlattice
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Microextrusion
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Package testing
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Polymer solution casting
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Reliability engineering
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Safety engineering
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Sintering
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Software of unknown pedigree
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Software reliability testing
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Stereolithography
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Sterility assurance level
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6. Regulatory Considerations
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21 CFR Part 11
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Center for Devices and Radiological Health
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Central Drugs Standard Control Organization
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China Food and Drug Administration
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Design controls
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Design history file
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Federal Food, Drug, and Cosmetic Act
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Food and Drug Administration Amendments Act of 2007
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Food and Drug Administration Modernization Act of 1997
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Food and Drug Administration
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Global Harmonization Task Force
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Global Medical Device Nomenclature
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Humanitarian Device Exemption
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IEC 60601
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IEC 62304
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IEC 62366
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ISO 10993
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ISO 13485
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ISO 14155
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ISO 14971
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ISO/IEEE 11073
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ISO/TC 215
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Italian Device Registration
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Medical Device Radiocommunications Service
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Medical Device Regulation Act
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Medical device reporting
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Medical Devices Directive
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Medicines and Healthcare Products Regulatory Agency
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Medsafe
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MedWatch
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Ministry of Food and Drug Safety
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Notified body
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Office of Global Regulatory Operations and Policy
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Pharmaceuticals and Medical Devices Agency
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Postmarketing surveillance
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Regulation of therapeutic goods
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Regulatory affairs
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Safe Medical Device Amendments of 1990
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Therapeutic Goods Administration
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Therapeutic Products Directorate
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Type approval
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7. Resources
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3M Health Care Ltd.
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Abbott Laboratories, Inc.
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Alcon, Inc.
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B. Braun Melsungen AG
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Baxter International, Inc.
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Bayer AG
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Becton, Dickinson and Company
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Boston Scientific Corporation
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Cardinal Health, Inc.
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Danaher Corporation
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Essilor International SA
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Fresenius SE & Co. KGaA
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GE Healthcare
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Getinge AB
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Hansen Medical, Inc.
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Intuitive Surgical, Inc.
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Johnson & Johnson, Inc.
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Medtronic PLC
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Olympus Corporation
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Philips Healthcare
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Smith & Nephew PLC
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St. Jude Medical, Inc.
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Stryker Corporation
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Zimmer Biomet Holdings, Inc.
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AdvaMed
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Association for the Advancement of Medical Instrumentation
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Canadian Medical and Biological Engineering Society
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COCIR
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International Medical Equipment Collaborative
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MedTech Europe
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