ISO 13485

ISO 13485 Medical Devices – Quality Management System

ISO 13485:2016 in Singapore helps laboratories to develop and upgrade their Quality Management Systems. It specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

The medical devices industry is one of the most highly regulated sectors globally, so it must demonstrate compliance with regulatory and product requirements to ensure the safety and performance of medical devices produced. To be distributed to medical industries, medical devices are required to meet the internationally recognized ISO 13485 standard. This is to ensure the safety and quality of your medical devices.

BENEFITS OF ISO 13485:

Trust in being a safe supplier and producer

Likelihood of meeting customer requirements and expectations

Reduce operation cost and production loss rate

Increase competitive advantage

Improve processes based on objective measurement

More effective risk management