medical device


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medical device

FDA
Any article or healthcare product intended for use in the diagnosis of disease or other condition, or for use in the care, treatment or prevention of disease, which does not achieve any of its primary intended purposes by chemical action or by being metabolised.
 
Examples
Diagnostic test kits, crutches, electrodes, pacemakers, catheters, intraocular lens.

Medical technology
An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease.

medical device

Any article or health care product intended for use in the diagnosis of disease or other condition or for use in the care, treatment, or prevention of disease that does not achieve any of its primary intended purposes by chemical action or by being metabolized Examples Diagnostic test kits, crutches, electrodes, pacemakers, catheters, intraocular lens. See Class I, II, III devices, Significant risk device, Silicone implant. Cf Nonsignificant risk.

medical device

Any health care product that is intended for the diagnosis, prevention, or treatment of disease and does not primarily work by effecting a chemical change in the body
See also: device
References in periodicals archive ?
Facing sharp changes of medical devices GMP regulations, how do you in compliance with the latest Chinese medical device GMP regulations, how do you operate business smoothly in China?
The Medical Device Act 2012 requires all medical device establishments to register and obtain permits and licenses from Malaysia's Ministry of Health.
Session 3 on "Specialty materials," will include the following presentations: "High and ultra high performance polymers for medical devices," Jean-Baptise Bonnadier, Solvay Advanced Polymers, Belgium; "Cutting edge polymers: The metal replacement op-tion for disposable devices," Mike Sullivan, Rosti Technical Plastics, the Netherlands; "Polyetheretherketone biomaterials for use in human implantable medical devices," Mark Dietlin, Invibio Ltd.
This non-profit educational institution specializes in medical device safety and procedures.
Nevertheless, the agency must comply with a 1976 law that contains a broad definition of what constitutes a medical device.
Poppe, DuPont SA, Switzerland; "Alcohol and lipid-resistant acrylic-based plastics for medical devices," Peter Colburn, Cyro Industries, and Craig Schmidter, Degussa AG, Germany; "SEBS thermoplastic elastomers in the medical and pharmaceutical industries," Bob Wells, Consolidated Polymer Technologies; "POSS-based polyurethanes: From degradable polymers to hydrogels," Patrick Mather, Haihu Qin and Kyung-Min Lee, Case Western Reserve University; and "New co-polyester solutions for medical devices and pharmaceutical packaging," Thijs Jaarsma, Eastman Chemical BV, The Netherlands.
MEDTEC is Europe's premier exhibition and conference for medical device development and manufacturing.
Medical Device Life Cycle: Product concept, requirements definitions, system architecture, product development/re-engineering, testing/certification, launch & field support and product sustenance & enhancements
Within this report the China medical devices market has been segmented based on the medical devices/products type and also by customers.
Before Ranier, Bill was VP, Market Development with MedSource Technologies, a leading medical engineering and manufacturing services provider to the medical device industry.

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