ISO 13485 is not a product standard. It’s a process standard . Therefore, it’s not enough to establish a quality management system that complies with the ISO 13485 standard, you also need to comply with all relevant product and service oriented technical standards and regulations.
- To establish a quality management system that is oriented towards the design, development, production, and installation of medical devices and related services.
- To demonstrate your ability to supply medical devices and related services those meets customer expectations and comply with regulatory requirements.
- T o evaluate how well your organization is able to meet customer expectations and comply with regulatory requirements.
- To become certified or registered.