Medical Devices
ISO 13485

What is it? 

This internationally-recognised standard is developed for businesses designing and manufacturing medical devices.

To compete in this highly regulated sector, businesses will need to demonstrate:

  • Conformity to medical device regulations
  • Commitment to creating high-quality products.

Achieving certification to this standard will help to drive your product and service improvement, reduce error rates and minimise associated waste and cost.

The ISO 13485 standard helps businesses demonstrate compliance with regulatory requirements, which can open doors to new business opportunities.