Documents

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BHARRGAVA GLOBAL

HR, Medical Device & Pharma Consultant

Procedure for Control of Document

Mandatory Documents Required for ISO 13485 : 2016 Compliance

Mandatory Records Required for ISO 13485 : 2016 Compliance

Part-1 : Risk Management Definition

Part-2 Risk Management Plan

Periodic Safety Update Report - PSUR

Change Control (Post approval change)

Good Documentation Practices

Personal Hygiene

Human Qualities

Preparation of Standard Operating Procedure

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