LVS EN ISO 13485:2016/A11:2021

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

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Medicīniskās ierīces. Kvalitātes pārvaldības sistēmas. Reglamentējošās prasības (ISO 13485:2016)

Languages: In English

Type: amendment

ICS groups: 11.040.01 Medical equipment in general, 03.100.70 Management systems *Standards included in this sub-group shall also be included in other groups and/or sub-groups according to their subject *Including environmental management systems (EMS), road traffic management systems, energy management systems, health care management systems, etc.

Technical commitee: CEN/CLC/TC 3 Quality management and corresponding general aspects for medical devices

Registred: 09.12.2021.
In force: 09.12.2021.

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