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Innhold levert av Terrence Baker and Association for the Advancement of Medical Instrumentation. Alt podcastinnhold, inkludert episoder, grafikk og podcastbeskrivelser, lastes opp og leveres direkte av Terrence Baker and Association for the Advancement of Medical Instrumentation eller deres podcastplattformpartner. Hvis du tror at noen bruker det opphavsrettsbeskyttede verket ditt uten din tillatelse, kan du følge prosessen skissert her https://no.player.fm/legal.
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AAMI Podcast 25: Changing Requirements for Quality Management Systems

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Manage episode 198758689 series 1281577
Innhold levert av Terrence Baker and Association for the Advancement of Medical Instrumentation. Alt podcastinnhold, inkludert episoder, grafikk og podcastbeskrivelser, lastes opp og leveres direkte av Terrence Baker and Association for the Advancement of Medical Instrumentation eller deres podcastplattformpartner. Hvis du tror at noen bruker det opphavsrettsbeskyttede verket ditt uten din tillatelse, kan du følge prosessen skissert her https://no.player.fm/legal.

Recognized by many jurisdictions around the world, the standard ANSI/AAMI/ISO 13485:2016, Medical Devices; Quality management systems; Requirements for regulatory purposes, provides structured guidance to help organizations meet regulatory requirements. In this episode, international quality and regulatory compliance consultant Eamonn Hoxey describes the major differences between the 2003 and 2016 editions of 13485. As we near the end of a three-year transition period for medical device developers and manufacturers to comply with requirements set forth in the 2016 edition of the standard, Hoxey discusses how the new updated version clarifies expectations for manufacturers, providing a much more global, comprehensive, and harmonized approach to meeting requirements.

Learn more at AAMI.org

  continue reading

34 episoder

Artwork
iconDel
 
Manage episode 198758689 series 1281577
Innhold levert av Terrence Baker and Association for the Advancement of Medical Instrumentation. Alt podcastinnhold, inkludert episoder, grafikk og podcastbeskrivelser, lastes opp og leveres direkte av Terrence Baker and Association for the Advancement of Medical Instrumentation eller deres podcastplattformpartner. Hvis du tror at noen bruker det opphavsrettsbeskyttede verket ditt uten din tillatelse, kan du følge prosessen skissert her https://no.player.fm/legal.

Recognized by many jurisdictions around the world, the standard ANSI/AAMI/ISO 13485:2016, Medical Devices; Quality management systems; Requirements for regulatory purposes, provides structured guidance to help organizations meet regulatory requirements. In this episode, international quality and regulatory compliance consultant Eamonn Hoxey describes the major differences between the 2003 and 2016 editions of 13485. As we near the end of a three-year transition period for medical device developers and manufacturers to comply with requirements set forth in the 2016 edition of the standard, Hoxey discusses how the new updated version clarifies expectations for manufacturers, providing a much more global, comprehensive, and harmonized approach to meeting requirements.

Learn more at AAMI.org

  continue reading

34 episoder

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