ISO 13485 Control Monitoring and Measuring devices

About the ISO 13485
Quality Management Glossary

Main Menu

Key Concepts

Content View Hits : 39309

ISO 13485 Control of Monitoring and Mesuring Devices requirements

ISO 13485 control of monitor and measurement devices

The organization shall define the monitoring and measurements required in order to provide evidences for product's conformity. Naturally, the requirements for monitoring and measurements are based on the medical device's requirements. When defining the requirements for product's monitoring and measurement, the organization shall refer to the next issues: