ISO 13485 Medical Devices -Quality Management System

ISO 13485 Medical Devices -Quality Management System

ISO 13485:2016 is an international standard that was created on the basis of the ISO 9001:2015 standard and contains special requirements for medical devices.

ISO 13485:2016 is the latest version of standard 13485. It is based on the ISO 9001:2015 process approach model.

In addition to fulfilling the legal requirements, medical device manufacturers who want to gain a competitive advantage must also prove that they comply with the quality management system requirements.

Benefits of ISO 13485 Certificate:

• It provides advantage and prestige against its competitors with ISO 13485 Certificate
• ISO 13485 reduces customer complaints.
• ISO 13485 Provides reduction in product errors.
• ISO 13485 System increases the profitability of the organization.