ISO 13485:2016 Medical Device Quality Management System

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support).

Below are key benefits of ISO 13485 implementation in any business related to medical devices manufacturing:

• Improve your company’s credibility and identity
• Evidence-based decision making
• Continual improvement
• Increased employee involvement
• Enhanced customer satisfaction