ISO 13485: 2016 Medical Devices Quality Management System

Medical devices quality management system determines the requirements for the design and development, production, facility and service of medical devices.

The quality management system requirements specified in the ISO 13485 standard are complementary to the technical requirements of the product. It is also one of the most important arguments that medical device manufacturers can use for CE marking. Within the scope of CE marking, if the production quality assurance module is selected, it is a system that companies should establish.

 

EN ISO 13485 What are the advantages?

The products will be able to show the health safety safety features and meet the minimum requirements with EN ISO 13485 certification and CE marking works.


Facilitates compliance with laws and regulations
Builds quality awareness for companies
Eliminate risks from finished products
Continuous provision of system activity.