ISO 13485 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 and applicable regulatory requirements.
Requirements of ISO 13485 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.
Why is ISO 13485 important to you?
ISO 13485 firmly ensures the use of best practices throughout all steps of a medical device's life cycle.
ISO 13485 serves as a regulatory or legal requirement in many countries
It assists in cutting costs, increasing efficiency and monitoring performance
It enables you to offer safer and more qualitative products and services to customers
ISO 13485 implementation ensures you continuous improvement