13485 PACK

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:

1. Resources, Personnel, Infrastructure, and Work Environment

2. QMS Requirements

3. Management Responsibility

4. Purchasing, Production, and Measuring Devices

5. Product Realization and Customer Relations

6. Design and Development

7. Measurement, Analysis, and Improvement, ...