Difference between revisions of "Book:Introduction to Medical Devices, Volume 2"
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This is the second of two volumes on an introductory view of medical devices. [[:Book:Introduction to Medical Devices, Volume 1|Volume 1]] included articles on what a medical device is, broad categories of medical devices, representative examples from each of those categories, and examples of medical procedures and techniques related to medical devices. It also included the first of two chapters on related medical device terminology. This volume continues on with that terminology and includes articles on regulatory information, manufacturers, organizations, and publications related to medical devices. | This is the second of two volumes on an introductory view of medical devices. [[:Book:Introduction to Medical Devices, Volume 1|Volume 1]] included articles on what a medical device is, broad categories of medical devices, representative examples from each of those categories, and examples of medical procedures and techniques related to medical devices. It also included the first of two chapters on related medical device terminology. This volume continues on with that terminology and includes articles on regulatory information, manufacturers, organizations, and publications related to medical devices. | ||
;5.2 Medical Device-Related Terminology - Part 2 | ;5.2 Medical Device-Related Terminology - Part 2 | ||
:''Health and Information Technology'' | |||
:[[Biomedical equipment technician]] | :[[Biomedical equipment technician]] | ||
:[[Chief medical informatics officer]] | :[[Chief medical informatics officer]] | ||
| Line 26: | Line 25: | ||
:[[Medical technology assessment]] | :[[Medical technology assessment]] | ||
:[[Telemedicine]] | :[[Telemedicine]] | ||
:''Design, Manufacturing, and Distribution'' | |||
:[[3D bioprinting]] | :[[3D bioprinting]] | ||
:[[3D printing]] | :[[3D printing]] | ||
| Line 48: | Line 46: | ||
:[[Stereolithography]] | :[[Stereolithography]] | ||
:[[Sterility assurance level]] | :[[Sterility assurance level]] | ||
;6. Regulatory Considerations | ;6. Regulatory Considerations | ||
:[[21 CFR Part 11]] | :[[21 CFR Part 11]] | ||
:[[Center for Devices and Radiological Health]] | :[[Center for Devices and Radiological Health]] | ||
| Line 93: | Line 89: | ||
:[[Therapeutic Products Directorate]] | :[[Therapeutic Products Directorate]] | ||
:[[Type approval]] | :[[Type approval]] | ||
;7. Resources | ;7. Resources | ||
:''Representative manufacturers'' | |||
:[[3M Company|3M Health Care Ltd.]] | :[[3M Company|3M Health Care Ltd.]] | ||
:[[Abbott Laboratories, Inc.]] | :[[Abbott Laboratories, Inc.]] | ||
| Line 122: | Line 116: | ||
:[[Stryker Corporation]] | :[[Stryker Corporation]] | ||
:[[Zimmer Biomet Holdings, Inc.]] | :[[Zimmer Biomet Holdings, Inc.]] | ||
:''Organizations'' | |||
:[[AdvaMed]] | :[[AdvaMed]] | ||
:[[Association for the Advancement of Medical Instrumentation]] | :[[Association for the Advancement of Medical Instrumentation]] | ||
| Line 130: | Line 123: | ||
:[[International Medical Equipment Collaborative]] | :[[International Medical Equipment Collaborative]] | ||
:[[MedTech Europe]] | :[[MedTech Europe]] | ||
:''Publications and awards'' | |||
:''[[Expert Review of Medical Devices]]'' | :''[[Expert Review of Medical Devices]]'' | ||
:''[[Journal of Medical Marketing]]'' | :''[[Journal of Medical Marketing]]'' | ||
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Introduction to Medical Devices (Volume 2)
This is the second of two volumes on an introductory view of medical devices. Volume 1 included articles on what a medical device is, broad categories of medical devices, representative examples from each of those categories, and examples of medical procedures and techniques related to medical devices. It also included the first of two chapters on related medical device terminology. This volume continues on with that terminology and includes articles on regulatory information, manufacturers, organizations, and publications related to medical devices.
- 5.2 Medical Device-Related Terminology - Part 2
- Health and Information Technology
- Biomedical equipment technician
- Chief medical informatics officer
- Clinical engineering
- Computer-aided diagnosis
- Computer-aided simple triage
- Health technology
- Health technology assessment
- In silico medicine
- Medical device connectivity
- Medical image computing
- Medical technology assessment
- Telemedicine
- Design, Manufacturing, and Distribution
- 3D bioprinting
- 3D printing
- Bioburden testing
- Biomedical engineering
- Direct metal laser sintering
- Electron beam additive manufacturing
- Lattice structure
- Medical device manufacturing
- Medical logistics
- Metallic microlattice
- Microextrusion
- Package testing
- Polymer solution casting
- Reliability engineering
- Safety engineering
- Sintering
- Software of unknown pedigree
- Software reliability testing
- Stereolithography
- Sterility assurance level
- 6. Regulatory Considerations
- 21 CFR Part 11
- Center for Devices and Radiological Health
- Central Drugs Standard Control Organization
- China Food and Drug Administration
- Design controls
- Design history file
- Federal Food, Drug, and Cosmetic Act
- Food and Drug Administration Amendments Act of 2007
- Food and Drug Administration Modernization Act of 1997
- Food and Drug Administration
- Global Harmonization Task Force
- Global Medical Device Nomenclature
- Humanitarian Device Exemption
- IEC 60601
- IEC 62304
- IEC 62366
- ISO 10993
- ISO 13485
- ISO 14155
- ISO 14971
- ISO/IEEE 11073
- ISO/TC 215
- Italian Device Registration
- Medical Device Radiocommunications Service
- Medical Device Regulation Act
- Medical device reporting
- Medical Devices Directive
- Medicines and Healthcare Products Regulatory Agency
- Medsafe
- MedWatch
- Ministry of Food and Drug Safety
- Notified body
- Office of Global Regulatory Operations and Policy
- Pharmaceuticals and Medical Devices Agency
- Postmarketing surveillance
- QSIT
- Regulation of therapeutic goods
- Regulatory affairs
- Safe Medical Device Amendments of 1990
- Therapeutic Goods Administration
- Therapeutic Products Directorate
- Type approval
- 7. Resources
- Representative manufacturers
- 3M Health Care Ltd.
- Abbott Laboratories, Inc.
- Alcon, Inc.
- B. Braun Melsungen AG
- Baxter International, Inc.
- Bayer AG
- Becton, Dickinson and Company
- Boston Scientific Corporation
- Cardinal Health, Inc.
- Danaher Corporation
- Essilor International SA
- Fresenius SE & Co. KGaA
- GE Healthcare
- Getinge AB
- Hansen Medical, Inc.
- Intuitive Surgical, Inc.
- Johnson & Johnson, Inc.
- Medtronic PLC
- Olympus Corporation
- Philips Healthcare
- Siemens Healthcare GmbH
- Smith & Nephew PLC
- St. Jude Medical, Inc.
- Stryker Corporation
- Zimmer Biomet Holdings, Inc.
- Organizations
- AdvaMed
- Association for the Advancement of Medical Instrumentation
- Canadian Medical and Biological Engineering Society
- COCIR
- International Medical Equipment Collaborative
- MedTech Europe
- Publications and awards
- Expert Review of Medical Devices
- Journal of Medical Marketing
- MD&DI
- Medical & Biological Engineering & Computing
- Medical Design Excellence Awards
