KS P ISO 13485:2007
Medical devices－Quality management systems－Requirements for regulatory purposes

Standard No.

KS P ISO 13485:2007

Release Date

2007

Published By

Korean Agency for Technology and Standards (KATS)

Status

Be replaced

Replace By

KS P ISO 13485:2018

Latest

KS P ISO 13485-2023

Replace

KS P ISO 13485:2002

Scope

All requirements of this standard apply to organizations supplying medical devices, regardless of their type or size.

KS P ISO 13485:2007 history

• 2023 KS P ISO 13485-2023 Medical devices — Quality management systems — Requirements for regulatory purposes
• 2018 KS P ISO 13485:2018 Medical devices — Quality management systems — Requirements for regulatory purposes
• 2007 KS P ISO 13485:2007 Medical devices－Quality management systems－Requirements for regulatory purposes
• 0000 KS P ISO 13485:2002