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17 April 2013
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New draft guidance documents released by the International Medical Device Regulators' Forum (IMDRF) aim to establish new standards for medical device auditing and monitoring organizations, as well as
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17 April 2013
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The International Medical Device Regulators' Forum (IMDRF), the regulators-only medical device harmonization group, has released a long-awaited major medical device proposal for industry comment
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10 April 2013
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The European Commission (EC) has announced the release of its recommendation on a framework for a unique device identification (UDI) system for medical devices marketed in the EU, bringing the country
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5 April 2013
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The most recent meeting of the International Medical Device Regulators Forum (IMDRF), the regulators-only successor group to the Global Harmonization Task Force (GHTF), indicates that the organization
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25 March 2013
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US Food and Drug Administration (FDA) regulator Kim Trautman, associate director of international affairs at the Center for Devices and Radiological Health (CDRH), told an audience of regulatory
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15 February 2013
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A new draft guidance document from the US Food and Drug Administration (FDA) regarding the accreditation process for firms utilizing its Third Party Review Program (TPRP) aims to establish a
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3 December 2012
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Australia’s Therapeutic Goods Administration (TGA) is implementing the Medical Device Single Audit Program (MDSAP), which aims to strengthen existing international cooperation in the field of medical
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28 November 2012
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So long, Global Harmonization Task Force (GHTF). The global medical device harmonization body has finally disbanded, leaving its unfinished work to the International Medical Device Regulators Forum
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Under RAPS
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30 October 2012
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The International Medical Device Regulators Forum (IMDRF) may be the newest global harmonization body, but you wouldn't know it by looking at its membership or its ambitions.The organization, launched
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1 May 2012
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The Asian Harmonization Working Party (AHWP) has announced it has been accepted as a member in both the International Medical Devices Regulators Forum (IMDRF) and the International Standards
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