Safety and quality are non-negotiables in the medical aesthetic industry. Regulatory requirements are increasingly stringent throughout every step of a product’s life cycle, including service and delivery. To ensure your are not only delivering the safest treatments to your clients, but also protecting yourself an your business its important to consider how safe a device is, before making your purchase decision.

WHAT IS ISO 13485?

ISO 13485 specifies requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organisations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support).

ISO 13485 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organisations.


 READ STANDARD REQUIREMENTS FOR CERTIFICATION.

You can read even more at www.iso.org.