Description

The ISO 13485 Chapter 7 Documentation Package focuses on Product Realization and includes essential documents to ensure that your organization effectively plans, develops, and delivers medical devices in compliance with ISO 13485:2016 standards.

• Product Realization Plan
• Customer Requirements Procedure
• Design and Development Procedure
• Design and Development Records
• Supplier Qualification Procedure
• Purchasing Procedure
• Production and
• Service
• Provision
• Procedure
• Control of Monitoring and
• Measuring
• Equipment Procedure