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1. MOST RECENT

   

   ISO 13485:2016▹

   Medical devices - Quality management systems - Requirements for regulatory purposes

   standard by International Organization for Standardization, 03/01/2016.

   Languages: English

   Historical Editions: ISO 13485:2016 Plus Redline, ISO/TR 14969:2004, ISO 13485 AND 14969 PACKAGE, ISO 13485:2003, ISO 13485:1996

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   • $185 PDF
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   • $305 Printed Edition + PDF

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2. MOST RECENT

   

   BS EN ISO 13485:2016+A11:2021▹

   Medical devices. Quality management systems. Requirements for regulatory purposes

   standard by British Standard / European Standard / International Organization for Standardization, 09/08/2021.

   Languages: English

   Historical Editions: BS EN ISO 13485:2016, BS EN ISO 13485:2012, BS EN ISO 13485:2003, BS EN ISO 13488:2001, BS EN ISO 13485:2001, BS EN 46003:1999, BS EN 46002:1997, BS EN 46001:1997, BS EN 46002:1994, BS EN 46001:1994

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   • $399 Secure PDF
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3. 

   NS-EN ISO 13485:2016▹

   Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

   standard by Standards Norway NS-EN ISO, 06/01/2016.

   Languages:

   Amendments, rulings, and supplements: NS-EN ISO 13485:2016/A11:2021

   Corrigenda: NS-EN ISO 13485:2016/AC:2018, NS-EN ISO 13485:2016/AC:2016

   Historical Editions: NS-EN ISO 13485:2012/AC:2012, NS-EN ISO 13485:2012, NS-EN ISO 13485:2003/AC:2009, NS-EN ISO 13485:2003/AC:2007, SN-CEN ISO/TR 14969:2005, NS-EN ISO 13485:2003, NS-EN ISO 13485:2000, NS-EN ISO 13488:2000, NS-EN 46003:1999, NS-EN 46001:1996, NS-EN 46002:1996, NS-EN 46001:1993

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4. MOST RECENT

   

   AAMI/ISO 13485:2016/(R)2019▹

   Medical devices - Quality management systems - Requirements for regulatory purposes

   standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 03/25/2016.

   Languages: English

   Historical Editions: AAMI/ISO 13485:2003/(R)2009, AAMI/ISO 13485:1996

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   • $275 PDF
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5. MOST RECENT

   

   ISO 13485:2016 - Medical Devices - A Practical Guide, Advice from ISO/TC 210▹

   Handbook / Manual / Guide by International Organization for Standardization, 01/01/2017.

   Languages: English

   Historical Editions: ISO 13485:2016, ISO 13485:2016 - Medical Devices - A Practical Guide

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   • $104 PDF
   • $104 Printed Edition
   • $172 Printed Edition + PDF

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6. MOST RECENT

   

   ISO/TR 24971:2020▹

   Medical devices - Guidance on the application of ISO 14971

   standard by International Organization for Standardization (Technical Report), 06/01/2020.

   Languages: English

   Historical Editions: ISO/TR 24971:2020 Plus Redline, ISO/TR 24971:2013

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   • $278 PDF
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7. 

   NS-EN ISO 13485:2016+AC:2018▹

   Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

   standard by Standards Norway NS-EN ISO, 06/01/2018.

   Languages:

   Historical Editions: NS-EN ISO 13485:2016+AC:2016

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8. 

   ISO 13485:2016 Procedures Package▹

   Training Material by 9000 Store, 2019.

   Languages: English

   Priced From:

   • $300 Self Extracting File

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9. 

   ISO 13485:2016 Forms Package▹

   Training Material by 9000 Store, 2019.

   Languages: English

   Priced From:

   • $100 Self Extracting File

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10. 

    ISO 13485:2016 Employee Training PPT▹

    Training Material by 9000 Store, 2019.

    Languages: English

    Priced From:

    • $85 Self Extracting File

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