ISO 13485:2016 — Medical Devices QMS
The international standard for quality management systems in the medical devices industry — demonstrating the ability to consistently provide safe, effective medical devices and related services.
ISO 13485:2016 specifies requirements for a Quality Management System specific to the medical devices industry. It is used by manufacturers and related service providers throughout the supply chain to demonstrate their ability to provide medical devices and related services that consistently meet customer requirements and applicable regulatory requirements.
Medical device manufacturers, distributors, importers, exporters, and service providers in the medical device supply chain. Required for CE marking (EU MDR), FDA registration, and many national health authority approvals.
- Required for medical device registration in many regulated markets
- Prerequisite for CE marking under EU MDR and IVDR
- Demonstrates compliance to customers and regulatory authorities
- Internationally recognised by health authorities globally
- Foundation for regulatory submissions and market access
- Strengthens risk management and post-market surveillance processes