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A medical device is an object which is used for medical purposes for human patients, for example in diagnosis, therapy or surgery. If applied to the human body, the effect of the medical device is primarily physical, in contrast to pharmaceutical drugs, which exert a biochemical effect. Specific regional definitions of medical device vary slightly as detailed below.

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Wikipedia About Medical Devices

A medical device is an object which is used for medical purposes for human patients, for example in diagnosis, therapy or surgery. If applied to the human body, the effect of the medical device is primarily physical, in contrast to pharmaceutical drugs, which exert a biochemical effect. Specific regional definitions of medical device vary slightly as detailed below.

(This paragraph of German: 2009-03-18)

Medical devices include a wide range of products varying in complexity and application. Examples include tongue depressors, medical thermometers, blood sugar meters, and X-ray machines.

European Union definition

Directive 2007/47/ec of the European Parliament and of the council of 5 September, 2007, which amended the Council Directive 93/42/EEC of 14 June, 1993 concerning medical devices, defines a medical device as any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings. Devices are to be used for the purpose of:

  • Diagnosis, prevention, monitoring, treatment or alleviation of disease.
  • Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap.
  • Investigation, replacement or modification of the anatomy or of a physiological process
  • Control of conception

This includes devices that do not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.

The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medical devices in the UK under European legislation. Medical devices must not be mistaken with medicinal products. In the EU, all medical devices must be identified with the CE mark.

Definition in USA by the Food and Drug Administration

A medical device, according to the U.S. Food and Drug Administration (FDA), is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

  • recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
  • intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
  • intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.

Search results for Medical Devices

Medical Device Technology Magazine

Home \ Magazines \ Medical Device Technology From the March/April Issue Implications of Material... European medical device manufacturers are sometimes ...www.devicelink.com/mdt/

IRB Information Sheets--Medical Devices (Updated 9/98)

FDA Information Sheets: 1998 Update - medical devices ... Significant Risk and Nonsignificant Risk Medical Device Studies ... IRB Review of Medical Devices ...www.fda.gov/oc/ohrt/irbs/devices.html

Medical Devices News & Diagnostics News from Medical News Today

The latest medical devices, diagnostics news headlines published daily ... Chemical Found In Medical Devices Impairs Heart Function ...www.medicalnewstoday.com/sections/medical_devices/

Medical Devices

View the Webcast Series: Designing and Validating Medical Devices with NI LabVIEW. Download the Medical Device Prototype Reference Architecture Resource Kit ...ni.com/medical

Medical Devices & Diagnostics - Johnson & Johnson

Advanced technology from our medical devices and diagnostics companies is used every day to save lives and restore the joy of living.www.jnj.com/connect/about-jnj/company-structure/medical-devi...

Images found for Medical Devices

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News about Medical Devices

Thermoelectric Temperature Chamber for Testing Implantable Medical Devices

PR.comTestEquity Model TEC1 is the world's first commercially available Thermoelectric Temperature Chamber. It was designed for engineering testing of pacemakers and defibrillators. Thermoelectric devices are ideally suited for this application, were just a little bit of cooling is required. The resulting design is quieter, more reliable, more compact, and weighs less than conventional refrigeration ...http://www.pr.com/press-release/151073

Cutting Edge: Medical device company trains students

New Haven RegisterNORTH HAVEN — Pawel Abramek’s face turns up a smile when he speaks about his internship at the Surgical Devices business unit of Covidien.http://nhregister.com/articles/2009/05/10/business/doc4a0497...

Covidien Acquires California-Based Medical Device Maker

Hartford CourantCovidien Ltd.'s acquisition of a California medical device maker adds a major piece to its medical devices division, which employs thousands of people in Connecticut.http://www.courant.com/business/hc-covidien-acquisition.artm...

Early Glance: Medical Devices companies

INO News(AP:NEW YORK) Shares of some top medical devices companies are mixed at 10 a.m.: Abbott Labs fell $.61 or 1.4 percent, to $43.13. Allergan rose $.82 or 1.7 percent, to $47.92.http://news.ino.com/headlines/?newsid=68980808668790

Push is on to put medical records online - Sun, 10 May 2009 PST

The Spokesman-ReviewThose who grew up in the pre-Internet world can remember having little access to their credit reports. Today, consumers easily can check and understand their credit scores online. Similarly, access to health records has been shrouded in mystery. But Microsoft, Google and Inland Northwest Health Services in Spokane want to change that, putting people more in control of their medical histories and ....http://www.spokesman.com/stories/2009/may/10/push-is-on-to-p...

News about Medical Devices

Thermoelectric Temperature Chamber for Testing Implantable Medical ...

PR.comTestEquity Model TEC1 is the world's first commercially available Thermoelectric Temperature Chamber. It was designed for engineering testing of pacemakers and defibrillators. Thermoelectric devices are ideally suited for this application, were just ... http://www.pr.com/press-release/151073

Chemical Found In Medical Devices Impairs Heart Function

Science DailyScienceDaily (May 3, 2009) — Researchers at the Johns Hopkins University School of Medicine have found that a chemical commonly used in the production of such medical plastic devices as intravenous (IV) bags and catheters can impair heart function ... http://www.sciencedaily.com/releases/2009/05/090501091022.ht...

Cleveland Clinic signs memorandum with Royal College of Surgeons in ...

Cleveland Plain DealerThe Cleveland Clinic signed a "memorandum of understanding" with the Royal College of Surgeons in Ireland on Thursday to work together to research, develop, test and eventually sell medical devices throughout Europe. The Royal College "is networked ... http://www.cleveland.com/healthfit/index.ssf/2009/05/clevela...

Covidien Acquires California-Based Medical Device Maker

Hartford CourantCovidien Ltd.'s acquisition of a California medical device maker adds a major piece to its medical devices division, which employs thousands of people in Connecticut. Massachusetts -based Covidien said Friday it agreed to buy VNUS of San Jose , Calif ... http://www.courant.com/business/hc-covidien-acquisition.artm...

Stretchable Nanotube Films May Advance Medical Electronics

PhysOrg(PhysOrg.com) -- One of the issues hindering the development of medical electronic devices capable of being implanted in the human body is the lack of suitable materials. Most semiconducting materials are stiff and brittle, while human tissue is soft ... http://www.physorg.com/news160652779.html

Search results for Medical Devices

Medical Device Recalls

Learn About Medical Device Recalls ... FDA > CDRH > Medical Device Recalls. Medical Device Recalls. FDA posts consumer information about the most serious medical device recalls.http://www.fda.gov/cdrh/recalls/

Medical Device Co.Ltd

http://www.medicaldevice.co.uk/

Patton Medical Devices - i-port® Injection Port

The i-port® is a simple medication delivery device that relieves the hardships of daily injections for individuals with diabetes and other chronic conditions. Developed by KK ... http://www.pattonmd.com/

Medical Devices - Drugs and Health Products - Main Page

Provides access to resources required for sale of medical devices in Canada including legislation, guidelines, applications and submissions, fees, licences and quality system ... http://www.hc-sc.gc.ca/dhp-mps/md-im/index_e.html

Medical Device Guru - Powered by vBulletin

Medical Device Forum for Med Device professionals. Daily Medical News, Emerging Medical Technologh Jobs, Interview Tips with emphasis on: Orthopedics, Imaging, Cardiovascular ... http://www.medicaldeviceguru.com/

Wikipedia results for Medical Devices

Medical device - Wikipedia, the free encyclopedia

A medical device is an object which is useful for diagnostic or therapeutic purposes. Examples of medical devices include medical thermometers, blood sugar meters, and X-ray ... http://en.wikipedia.org/wiki/Medical_device

Medical Devices Directive - Wikipedia, the free encyclopedia

The Medical Devices Directive (Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, OJ No L 169/1 of 1993-07-12) is intended to harmonise the laws relating to ... http://en.wikipedia.org/wiki/Medical_devices_directive

Gag (medical device) - Wikipedia, the free encyclopedia

In the context of surgery or dental surgery, a gag is a device used to hold the patient 's mouth open when working in the oral cavity, or to force the mouth open when it cannot ... http://en.wikipedia.org/wiki/Gag_%28medical_device%29

Biomedical engineering - Wikipedia, the free encyclopedia

Most medical devices are either inherently safe, or have added devices and systems so that they can sense their failure and shut down into an unusable, thus very safe state.http://en.wikipedia.org/wiki/Medical_engineering

Cane (medical device) - Wikipedia, the free encyclopedia

A Cane (or walking stick) is a stability device used for the facilitation of balanced movement. Hemiplegic and balance-impaired persons use the stick to give them a better sense of ... http://en.wikipedia.org/wiki/Cane_(medical_device)
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Answers for Medical Devices

BenWhat are the US taxes and Tarriff for importing consumer medical devices to the USA?BenThe Tariffs from US Customs & Border Patrol are here:mahmoodHow can i get a service manual for medical devices?mahmoodCan you contact the manufacturer and order one?Investigator XHow different is it to get approval from Health Canada vs the FDA for drugs and medical devices?Investigator XIn Canada, everything has to go through a rigorous testing process before it can be released to the public, but you can get generic versions of drugs much sooner than in the USA; I think it's twenty y...jackzhlinWhich country on this planet makes the most advanced medical devices?jackzhlinGermanymemorrhageWhat are the factors that make the clinical trials the most reasonable means to test a new medical devices?memorrhagewe've had one lecture on this......the points that i managed to pick up is that clinical trials are good if they are randomised, double-blinded and placebo-controlled. because then the trials can be g...
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