Medical Devices Regulatory Agency

When the U.S. Food and Drug Administration approved implanting microchips in humans, the manufacturer said it would save lives, letting doctors scan the tiny transponders to access patients medical records almost instantly. The FDA found reasonable assurance the device was safe, and a sub-agency even called it one of 2005 s top innovative technologies …Read more...

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Medical Devices Industry Outlook

Medical Devices Industry Outlook

Quality, Efficiency, Regulatory Compliance. With broad coverage ranging from Equipment Integration, Operations Management Data Analysis Production, this version provides a solution cmNAVIGO one-stop-shop for the most demanding production requirements for Medical Devices. Despite the high flexibility...
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China Medical devices Class

China Medical devices Class

Market approval Service Europe - CE marking TV SD is a Notified Body identification number (0123) of the European Union and may conformity assessment according to EU directives perform that are, which is mandatory for all products imported into the EU. We audit quality management systems, test...
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European Medical devices Reporting

European Medical devices Reporting

HOSPITAL: March 2007 10 questions on the medical device The medical device is intended to prevent the occurrence of serious incidents involving medical devices, through preventive or corrective action. The medical device is intended to monitor incidents or potential incidents resulting from...
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Medical devices in European Union

Medical devices in European Union

How to define medical devices for in vitro diagnostic (IVD)? According to the Decree-Law n. 189/2 of 12 August, which transposes Directive 98/79/EC, DIV is: any medical device in vitro diagnostic which is a reagent, reagent product, calibrator, control material, assembly, instrument, apparatus...
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China Medical device Consulting

China Medical device Consulting

For manufacturers of electronic medical devices looking to sell its products in Brazil, may be required testing and certification of electrical safety from the National Institute of Metrology, Standardization and Industrial Quality (INMETRO) in order to obtain the record of the National Agency...
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Medical Devices Industry 2012

Medical Devices Industry 2012

Press release - According to a Cochrane review, clinical trials funded by the pharmaceutical industry reported a more favorable framework of the effects of drugs and medical devices than non-sponsored. The researchers are calling for a careful evaluation and management of possible bias (bias)...
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Medical device implants Companies

Medical device implants Companies

Der jngste Eklat in der Medizintechnik hat eher unscheinbar begonnen. Frankfurt / Paris The recent scandal in medical technology has begun rather unimpressive. But now, a scandal developed with sufficient urgency to provide the legal framework for the entire medtech industry into question...
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European Medical devices symbols

European Medical devices symbols

03 May. 2013 Identification of medical devices and medicinal products subject to special monitoring The month of March was published Regulation (EU) No 198/2013 on the new identification symbol shall incorporate the drugs whose authorization is subject to additional monitoring. Publication... Read More

Australian medical device company

Australian medical device company

If your company does not have a physical location within the country, Australian law dictates that you must appoint a sponsor who is located in Australia to act as its liaison with the Therapeutic Goods Administration (TGA). Emergo is an official sponsor for Australia with physical offices... Read More

EU Medical devices regulatory

EU Medical devices regulatory

REPORT 1. CONTEXT OF THE PROPOSAL The current EU regulatory framework for medical devices for in vitro diagnostic ( IVD ) is given by Directive 98/79/EC of the European Parliament and of the Council ( IVD Directive ) [1]. Among the IVD comprises a wide range of products that can be used for... Read More

Medical Devices Conference China

Medical Devices Conference China

Trade Request our services through this form. Discover all the shows in China in 2013 in the months of: SEPTEMBER Fairs in China China (Beijing) Medical Devices Exhibition 2 to 4 September 2013 | Beijing,China Medications: China,Beijing Exhibition medical devices aimed at what the current state... Read More

Syracuse medical device Companies

Syracuse medical device Companies

PF Louis Since the ancient Greek and Roman silver is used as an antimicrobial agent for preservation of food or liquids and medicine. Than conventional medicine in the early 20th Century in medical practice gained the upper hand,put one hand only to synthetic drugs. But with abebbender antibiotic... Read More