ISO 13485:2016 Medical Devices — Quality Management System
What is Medical Devices Management System?
This standard specifies the requirements of a quality management system that can be used for the design, development and provision of services related to the design and development, production, facility and service of medical devices. It is based on the ISO 9001 Process model and standard structure approach.
The main purpose of the standard is to facilitate medical device legislation requirements. In Europe and America, it has become mandatory for medical device manufacturers to use and implement a system in accordance with the ISO 13485 standard.
It is required for companies that provide design, production, assembly, development, service and sales services for the devices included in the Medical Device Regulation published by the Ministry of Health.
What are the Benefits of ISO 13485 Medical Devices Management System?
• It will help you set up your system in order to gain CE mark for your products,
• It will help you build trust towards your customers,
• It will provide competitive advantage in national and international markets,
• By fulfilling the reliability aspects of your product, it will reduce the negative effects of your product,
• It will improve your system and reduce customer complaints.