In order to comply with the regulatory requirements, as well as with the requirements of the AEMPS in Spain or of the competent authorities of other countries, manufacturers, groupers, sterilizers, importers and distributors should have a quality management system implemented, the requirements and obligations of which are defined in the regulations and legislation that apply to them.
The international standard for medical devices that defines the requirements of the quality management system for regulatory purposes is ISO 13485, and each country may have additional requirements.
