ISO 13485

ISO 13485 lays forth the requirements for a quality management system. According to these specifications, a company has to show that it can provide medical equipment and related services that regularly satisfy the customer’s needs and any relevant legal or regulatory requirements. These organizations could be engaged in one or more phases of the device’s life cycle, which could involve the creation and advancement, manufacturing, transportation, storage, installation, or maintenance of a medical device, as well as the creation and advancement or supply of related services (like technical support). The International Organization for Standardization ISO 13485 is also available to vendors or other outside parties that provide these companies with products or services, particularly those related to quality management systems.

Except in those cases where it is expressly stated, all enterprises, regardless of size or kind, must adhere to the criteria of ISO 13485. The connected services offered by the organization are subject to the same criteria stated as being relevant to medical devices. In compliance with ISO 13485, the organization is responsible for procedures that are relevant to it but are not carried out by it. The organization’s quality management system considers these processes by monitoring, maintaining, and controlling them.

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