Medical Devices
ISO 13485

What is it? 

This internationally recognised standard has been developed specifically for businesses manufacturing medical devices.

To maximise business opportunity in this highly regulated sector, businesses will need to not only demonstrate their conformity to the regulations but also show their commitment to the provision of consistently high-quality products.

Implementing a system of process control will help to drive product and service improvement and reduce error rates and associated waste and cost.

The ISO 13485 standard helps businesses to demonstrate their credibility and to manage operations and risk more effectively and will open doors to new business opportunities.