Quality Management System for Medical Devices ISO 13485:2016

ISO 13485: 2016 sets out the requirements for a Quality Management System specific to the medical devices industry, according to which an organization provides safe and effective medical devices and fulfils regulatory requirements.

ISO 13485: 2016 is applicable to any organization in design, development, production, storage, distribution, sales, installation and technical support of medical devices regardless of size or type.

BENEFITS of ISO 13485: 2016

• Increase in customer satisfaction
• Safe products
• Compliance with legislative and regulatory requirements.
• Improvement in the quality of the product