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prSRPS CEN ISO/TS 23485:2026

Medicinska sredstva -- Sistemi menadžmenta kvalitetom -- Smernice za primenu ISO 13485:2016

Medical Devices -- Quality management systems -- Guideline for the application of ISO 13485:2016

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10.99     18. 4. 2025.

ISS

Z076

Tehnička specifikacija

engleski  

Apstrakt

This document provides guidance on the intent of the requirements in ISO 13485:2016, with examples of possible steps an organization can take to meet the requirements. It does not add to, subtract from, or in any way modify those requirements.

The document does not prescribe mandatory approaches to implementation or provide any preferred method of interpretation.

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prSRPS CEN ISO/TS 23485:2026
10.99 Novi projekat se prihvata
18. 4. 2025.

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Identičan sa prCEN ISO/TS 23485 IDENTICAL

Identičan sa ISO/CD TS 23485 IDENTICAL