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DescriptionDetails & specsAttachments
This procedure has been created in accordance with ISO 13485:2016, Regulation 2017/745, MDCG 2022-21 (December 2022), MDCG 2023-3 (January 2025), MDCG 2020-7 (April 2020), MDCG 2020-8 (April 2020) and GHTF/SG5/N4 Post Market Clinical Follow-up Studies.
It can be used by medical device manufacturers in their Quality Management System.
It contains predefined sections and provides recommended guidance for filling in content.
15 pages
It can be used by medical device manufacturers in their Quality Management System.
It contains predefined sections and provides recommended guidance for filling in content.
15 pages
Language
English