13485 PACK
Quality Management System
Quality Management System
This package provides a step-by-step guide for installing a quality management system in compliance with MDR EU 2017/745 Article 10.9 and ISO 13485. You will receive all necessary document, SOP- templates and detailed instructions, which should be tailored to fit your company's specific resources, personnel, infrastructure, and work environment.
Overview:
Resources, Personnel, Infrastructure, and Work Environment
QMS Requirements
Management Responsibility
Purchasing, Production, and Measuring Devices
Product Realization and Customer Relations
Design and Development
Measurement, Analysis, and Improvement, ...