1 Keep your patients protected with an ISO-certified biomedical equipment provider What is ISO 13485:2016? It’s a customer patient-focused quality management system to help ensure medical devices support patient safety and quality standards. It outlines requirements that organizations need to adhere to in order to demonstrate their ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Who needs to follow it? Organizations involved in the design, production, installation and servicing of medical devices and related services. What are some of the requirements? Requirements in maintaining the effectiveness of a quality management system include: • Documented procedures to maintain an effectiv

Join for free to read