Book:Introduction to Medical Devices, Volume 2

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Introduction to Medical Devices
Volume 2
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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
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
Package testing
Polymer solution casting
Reliability engineering
Safety engineering
Software of unknown pedigree
Software reliability testing
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
Ministry of Food and Drug Safety
Notified body
Office of Global Regulatory Operations and Policy
Pharmaceuticals and Medical Devices Agency
Postmarketing surveillance
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.
Association for the Advancement of Medical Instrumentation
Canadian Medical and Biological Engineering Society
International Medical Equipment Collaborative
MedTech Europe
Publications and awards
Expert Review of Medical Devices
Journal of Medical Marketing
Medical & Biological Engineering & Computing
Medical Design Excellence Awards