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5. Implant-related Medical Conditions
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Adhesion (medicine)
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Aneurysm
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Ascites
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Atrial septal defect
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Bone fracture
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Bradycardia
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Breast cancer
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Cancer
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Cataract
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Chronic pain
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Diabetes mellitus
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Disfigurement
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Dystrophic calcification
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Epilepsy
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Erectile dysfunction
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Fecal incontinence
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Gastroesophageal reflux disease
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Gastroparesis
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Glaucoma
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Hearing loss
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Heart failure
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Hydrocephalus
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Hypertrophic cardiomyopathy
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Keratoconus
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Laryngeal cancer
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Metallosis
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Obesity
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Organ dysfunction
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Osteoarthritis
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Otitis media
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Otosclerosis
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Paraplegia
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Parkinson's disease
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Pulmonary embolism
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Respiratory failure
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Retinitis pigmentosa
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Rheumatoid arthritis
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Scoliosis
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Sinusitis
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Sleep apnea
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Spinal stenosis
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Spondylolisthesis
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Syncope (medicine)
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Treatment-resistant depression
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Unintended pregnancy
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Urinary incontinence
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Urinary retention
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Valvular heart disease
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Ventricular fibrillation
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Ventricular septal defect
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Ventricular tachycardia
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Visual impairment
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6. Implant-related Terminology
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Adverse event
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Biocompatibility
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Biofunctionalization
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Capsular contracture
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Cell encapsulation
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Heart nanotechnology
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Implant failure
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Nanotopography
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Neuromechanics of orthoses
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Neurotechnology
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Osseointegration
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Pacemaker failure
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Surface chemistry of neural implants
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Surface and bulk erosion
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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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Minusheet perfusion culture system
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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 reliability testing
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Stereolithography
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Sterility assurance level
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7. 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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Software of unknown pedigree
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Therapeutic Goods Administration
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Therapeutic Products Directorate
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Type approval
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8. Resources
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Abbott Laboratories, Inc.
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Abiomed, Inc.
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Alcon, Inc.
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Allergan, Plc
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Bausch & Lomb, Inc.
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Bayer AG
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Berlin Heart GmbH
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Biotronik SE & Co. KG
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Boston Scientific Corporation
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DePuy Synthes, Inc.
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Glaukos Corporation
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Intersect ENT, Inc.
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Medtronic PLC
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Mentor Worldwide, LLC
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MetaCure Ltd.
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Navilyst Medical, Inc.
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Novartis International AG
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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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SynCardia Systems, Inc.
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Teva Pharmaceutical Industries Ltd.
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Zimmer Biomet Holdings, Inc.
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AdvaMed
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American Society for Artificial Internal Organs
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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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Cyborg Foundation
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MedTech Europe
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