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EN ISO 13485:2016/AC:2018 Standard

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  Keywords:

#quality #purposes #regulatory #requirements #systems

  Directive

In vitro diagnostic medical devices Directive (98/79/EC)

  Last Official Journal reference

Thursday 15th of April 2021

  Description:

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

  Purpose

Corrigendum for EN ISO 13485:2016

  Publication

Wednesday 25th of March 2020

  Correction

This standard is a correction for "EN ISO 13485:2016"

  Related Standards

EN ISO 13408-7:2015

In vitro diagnostic medical devices Directive (98/79/EC)

Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408...

EN 14136:2004

In vitro diagnostic medical devices Directive (98/79/EC)

Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures

EN ISO 13408-6:2011

In vitro diagnostic medical devices Directive (98/79/EC)

Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)

EN ISO 18113-5:2011

In vitro diagnostic medical devices Directive (98/79/EC)

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instrumen...

EN ISO 13485:2016

In vitro diagnostic medical devices Directive (98/79/EC)

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

EN ISO 13485:2016/AC:2016

In vitro diagnostic medical devices Directive (98/79/EC)

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

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