Difference between revisions of "Book:Introduction to Implants, Volume 2"
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==''Introduction to Implants: Devices, Procedures, and Conditions Requiring Them'' (Volume 2) == | ==''Introduction to Implants: Devices, Procedures, and Conditions Requiring Them'' (Volume 2) == | ||
This is the second of two volumes on the topic of implantable medical devices. [[:Book:Introduction to Implants, Volume 1|Volume 1]] included articles on what a medical device and an implant are, types of implants, | This is the second of two volumes on the topic of implantable medical devices. [[:Book:Introduction to Implants, Volume 1|Volume 1]] included articles on what a medical device and an implant are, types of implants, the biomaterials used in the manufacture or implants, and medical procedures utilizing them.. This volume continues on with articles about medical conditions necessitating or caused by an implant, implant terminology, regulatory information, and implant-related resources. | ||
;5. Implant-related Medical Conditions | ;5. Implant-related Medical Conditions | ||
:[[Adhesion (medicine)]] | :[[Adhesion (medicine)]] | ||
:[[Aneurysm]] | :[[Aneurysm]] | ||
| Line 72: | Line 41: | ||
:[[Organ dysfunction]] | :[[Organ dysfunction]] | ||
:[[Osteoarthritis]] | :[[Osteoarthritis]] | ||
:[[Otitis media]] | |||
:[[Otosclerosis]] | :[[Otosclerosis]] | ||
:[[Paraplegia]] | :[[Paraplegia]] | ||
| Line 94: | Line 64: | ||
:[[Ventricular tachycardia]] | :[[Ventricular tachycardia]] | ||
:[[Visual impairment]] | :[[Visual impairment]] | ||
;6. Implant-related Terminology | ;6. Implant-related Terminology | ||
:[[Adverse event]] | |||
:[[Biocompatibility]] | :[[Biocompatibility]] | ||
:[[Biofilm]] | |||
:[[Biofunctionalization]] | |||
:[[Capsular contracture]] | :[[Capsular contracture]] | ||
:[[Cell encapsulation]] | :[[Cell encapsulation]] | ||
:[[Chemistry of biofilm prevention]] | |||
:[[Heart nanotechnology]] | :[[Heart nanotechnology]] | ||
:[[Implant failure]] | :[[Implant failure]] | ||
| Line 110: | Line 82: | ||
:[[Surface chemistry of neural implants]] | :[[Surface chemistry of neural implants]] | ||
:[[Surface and bulk erosion]] | :[[Surface and bulk erosion]] | ||
:''Manufacturing and Distribution'' | :''Manufacturing and Distribution'' | ||
:[[3D bioprinting]] | :[[3D bioprinting]] | ||
| Line 119: | Line 90: | ||
:[[Electron beam additive manufacturing]] | :[[Electron beam additive manufacturing]] | ||
:[[Crystal structure|Lattice structure]] | :[[Crystal structure|Lattice structure]] | ||
:[[Medical device manufacturing]] | |||
:[[Medical logistics]] | :[[Medical logistics]] | ||
:[[Metallic microlattice]] | :[[Metallic microlattice]] | ||
| Line 128: | Line 100: | ||
:[[Safety engineering]] | :[[Safety engineering]] | ||
:[[Sintering]] | :[[Sintering]] | ||
:[[Software reliability testing]] | |||
:[[Stereolithography]] | |||
:[[Sterility assurance level]] | :[[Sterility assurance level]] | ||
;7. Regulatory Considerations | ;7. Regulatory Considerations | ||
:[[21 CFR Part 11]] | :[[21 CFR Part 11]] | ||
:[[Center for Devices and Radiological Health]] | :[[Center for Devices and Radiological Health]] | ||
| Line 161: | Line 133: | ||
:[[Medicines and Healthcare Products Regulatory Agency]] | :[[Medicines and Healthcare Products Regulatory Agency]] | ||
:[[Medsafe]] | :[[Medsafe]] | ||
:[[MedWatch]] | |||
:[[Ministry of Food and Drug Safety]] | :[[Ministry of Food and Drug Safety]] | ||
:[[Notified body]] | :[[Notified body]] | ||
:[[Office of Global Regulatory Operations and Policy]] | |||
:[[Pharmaceuticals and Medical Devices Agency]] | :[[Pharmaceuticals and Medical Devices Agency]] | ||
:[[Postmarketing surveillance]] | :[[Postmarketing surveillance]] | ||
| Line 169: | Line 143: | ||
:[[Regulatory affairs]] | :[[Regulatory affairs]] | ||
:[[Safe Medical Device Amendments of 1990]] | :[[Safe Medical Device Amendments of 1990]] | ||
:[[Software of unknown pedigree]] | |||
:[[Therapeutic Goods Administration]] | :[[Therapeutic Goods Administration]] | ||
:[[Therapeutic Products Directorate]] | :[[Therapeutic Products Directorate]] | ||
:[[Type approval]] | :[[Type approval]] | ||
;8. Resources | ;8. Resources | ||
:''Manufacturers'' | :''Manufacturers'' | ||
:[[Abbott Laboratories, Inc.]] | :[[Vendor:Abbott Laboratories, Inc.|Abbott Laboratories, Inc.]] | ||
:[[Abiomed, Inc.]] | :[[Vendor:Abiomed, Inc.|Abiomed, Inc.]] | ||
:[[Alcon, Inc.]] | :[[Vendor:Alcon, Inc.|Alcon, Inc.]] | ||
:[[Allergan, Plc]] | :[[Vendor:Allergan, Plc|Allergan, Plc]] | ||
:[[Bausch & Lomb, Inc.]] | :[[Vendor:Bausch & Lomb, Inc.|Bausch & Lomb, Inc.]] | ||
:[[Bayer AG]] | :[[Vendor:Bayer AG|Bayer AG]] | ||
:[[Berlin Heart GmbH]] | :[[Vendor:Berlin Heart GmbH|Berlin Heart GmbH]] | ||
:[[Biotronik SE & Co. KG]] | :[[Vendor:Biotronik SE & Co. KG|Biotronik SE & Co. KG]] | ||
:[[Boston Scientific Corporation]] | :[[Vendor:Boston Scientific Corporation|Boston Scientific Corporation]] | ||
:[[DePuy Synthes, Inc.]] | :[[Vendor:DePuy Synthes, Inc.|DePuy Synthes, Inc.]] | ||
:[[Glaukos Corporation]] | :[[Vendor:Glaukos Corporation|Glaukos Corporation]] | ||
:[[Intersect ENT, Inc.]] | :[[Vendor:Intersect ENT, Inc.|Intersect ENT, Inc.]] | ||
:[[Medtronic PLC]] | :[[Vendor:Medtronic PLC|Medtronic PLC]] | ||
:[[Mentor Worldwide, LLC]] | :[[Vendor:Mentor Worldwide, LLC|Mentor Worldwide, LLC]] | ||
:[[MetaCure Ltd.]] | :[[Vendor:MetaCure Ltd.|MetaCure Ltd.]] | ||
:[[Navilyst Medical, Inc.]] | :[[Vendor:Navilyst Medical, Inc.|Navilyst Medical, Inc.]] | ||
:[[Novartis International AG]] | :[[Vendor:Novartis International AG|Novartis International AG]] | ||
:[[Smith & Nephew PLC]] | :[[Vendor:Smith & Nephew PLC|Smith & Nephew PLC]] | ||
:[[St. Jude Medical, Inc.]] | :[[Vendor:St. Jude Medical, Inc.|St. Jude Medical, Inc.]] | ||
:[[Stryker Corporation]] | :[[Vendor:Stryker Corporation|Stryker Corporation]] | ||
:[[SynCardia Systems, Inc.]] | :[[Vendor:SynCardia Systems, Inc.|SynCardia Systems, Inc.]] | ||
:[[Teva Pharmaceutical Industries Ltd.]] | :[[Vendor:Teva Pharmaceutical Industries Ltd.|Teva Pharmaceutical Industries Ltd.]] | ||
:[[Zimmer Biomet Holdings, Inc.]] | :[[Vendor:Zimmer Biomet Holdings, Inc.|Zimmer Biomet Holdings, Inc.]] | ||
:''Organizations'' | :''Organizations'' | ||
:[[AdvaMed]] | :[[AdvaMed]] | ||
| Line 208: | Line 180: | ||
:[[Cyborg Foundation]] | :[[Cyborg Foundation]] | ||
:[[MedTech Europe]] | :[[MedTech Europe]] | ||
:''Publications and awards'' | |||
:''Publications'' | |||
:''[[Expert Review of Medical Devices]]'' | :''[[Expert Review of Medical Devices]]'' | ||
:''[[Journal of Medical Marketing]]'' | :''[[Journal of Medical Marketing]]'' | ||
:''[[MD&DI]]'' | :''[[MD&DI]]'' | ||
:''[[Medical & Biological Engineering & Computing]]'' | :''[[Medical & Biological Engineering & Computing]]'' | ||
:[[Medical Design Excellence Awards]] | |||
<!--Place all category tags here--> | <!--Place all category tags here--> | ||
[[Category:LIMSwiki books on healthcare]] | [[Category:LIMSwiki books on healthcare]] | ||
[[Category:LIMSwiki books on medical devices]] | |||
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Introduction to Implants: Devices, Procedures, and Conditions Requiring Them (Volume 2)
This is the second of two volumes on the topic of implantable medical devices. Volume 1 included articles on what a medical device and an implant are, types of implants, the biomaterials used in the manufacture or implants, and medical procedures utilizing them.. This volume continues on with articles about medical conditions necessitating or caused by an implant, implant terminology, regulatory information, and implant-related resources.
- 5. Implant-related Medical Conditions
- Adhesion (medicine)
- Aneurysm
- Ascites
- Atrial septal defect
- Bone fracture
- Bradycardia
- Breast cancer
- Cancer
- Cataract
- Chronic pain
- Diabetes mellitus
- Disfigurement
- Dystrophic calcification
- Epilepsy
- Erectile dysfunction
- Fecal incontinence
- Gastroesophageal reflux disease
- Gastroparesis
- Glaucoma
- Hearing loss
- Heart failure
- Hydrocephalus
- Hypertrophic cardiomyopathy
- Keratoconus
- Laryngeal cancer
- Metallosis
- Obesity
- Organ dysfunction
- Osteoarthritis
- Otitis media
- Otosclerosis
- Paraplegia
- Parkinson's disease
- Pulmonary embolism
- Respiratory failure
- Retinitis pigmentosa
- Rheumatoid arthritis
- Scoliosis
- Sinusitis
- Sleep apnea
- Spinal stenosis
- Spondylolisthesis
- Syncope (medicine)
- Treatment-resistant depression
- Unintended pregnancy
- Urinary incontinence
- Urinary retention
- Valvular heart disease
- Ventricular fibrillation
- Ventricular septal defect
- Ventricular tachycardia
- Visual impairment
- 6. Implant-related Terminology
- Adverse event
- Biocompatibility
- Biofilm
- Biofunctionalization
- Capsular contracture
- Cell encapsulation
- Chemistry of biofilm prevention
- Heart nanotechnology
- Implant failure
- Nanotopography
- Neuromechanics of orthoses
- Neurotechnology
- Osseointegration
- Pacemaker failure
- Staphylococcus epidermidis
- Surface chemistry of neural implants
- Surface and bulk erosion
- 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
- Minusheet perfusion culture system
- Package testing
- Polymer solution casting
- Reliability engineering
- Safety engineering
- Sintering
- Software reliability testing
- Stereolithography
- Sterility assurance level
- 7. 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
- Software of unknown pedigree
- Therapeutic Goods Administration
- Therapeutic Products Directorate
- Type approval
- 8. Resources
- Manufacturers
- Abbott Laboratories, Inc.
- Abiomed, Inc.
- Alcon, Inc.
- Allergan, Plc
- Bausch & Lomb, Inc.
- Bayer AG
- Berlin Heart GmbH
- Biotronik SE & Co. KG
- Boston Scientific Corporation
- DePuy Synthes, Inc.
- Glaukos Corporation
- Intersect ENT, Inc.
- Medtronic PLC
- Mentor Worldwide, LLC
- MetaCure Ltd.
- Navilyst Medical, Inc.
- Novartis International AG
- Smith & Nephew PLC
- St. Jude Medical, Inc.
- Stryker Corporation
- SynCardia Systems, Inc.
- Teva Pharmaceutical Industries Ltd.
- Zimmer Biomet Holdings, Inc.
- Organizations
- AdvaMed
- American Society for Artificial Internal Organs
- Association for the Advancement of Medical Instrumentation
- Canadian Medical and Biological Engineering Society
- COCIR
- Cyborg Foundation
- MedTech Europe
- Publications and awards
- Expert Review of Medical Devices
- Journal of Medical Marketing
- MD&DI
- Medical & Biological Engineering & Computing
- Medical Design Excellence Awards
