What is ISO 13485?
ISO 13485 is a quality management system that establishes regulatory requirements for medical device manufacturers. This document, which is an international standard, has been prepared for the purpose of structuring companies that provide medical device service.
This standardization regulation was first published by the ISO (International Organization for Standardization) in 1996.
ISO 13485, which has been revised until today, meets the need for a comprehensive management approach in the design and production of medical devices.
ISO 13485, which has been revised until today, meets the need for a comprehensive management approach in the design and production of medical devices.
What does the ISO 13485 Standard do?
Medical device manufacturers conduct studies in an area of activity directly related to human health.
Since it is a business that needs attention, companies producing medical devices are obliged to meet the current legal obligations. ISO 13485 is the quality control system standard in force to audit services in this context.
The main purpose of this standard is to check that medical devices take place in the market effectively and reliably without harming human health. This standard is an international standard type where the quality management system criteria determined by ISO focus on medical devices.
What is ISO 13485:2016, what does it mean?
ISO 13485 draws a broad-framed management approach to medical device design and design. This understanding includes the rules and conditions that companies must comply with in the production and market of medical devices. This standard is an ISO standard that enables the production of medical devices focused on protecting human health and environmental health. ISO 13485:2016 means that this standard was updated in 2016 and is currently in force.
What is ISO 13485 Certificate?
The ISO 13485 standard, which also concerns organizations operating in the medical device production and service sector, lays the groundwork for the production and service of medical devices in accordance with legal regulations. Organizations that have ISO 13485 certificate declare that they comply with the rules and conditions underlined by ISO and that they serve in a healthy way.
