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Q M S

Quality Management System

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Quality Management System
Writing and documentation


1. The Quality department of Negativeconsulting has expertise in establishing and documentations as per
·     ISO 13485, Quality management system for Medical Devices,
·     ISO 15378, Quality Management System for Primary Packaging for Medicinal Products and
·     ISO 9001, Quality Management System.

2. Preparing of Design History File 21 CFR 820.30.
 
3. cGMP competent documentation 21 CFR 210 and 21 CFR 211