Quality standards for medical devices are essential to ensure that products meet safety, effectiveness, and regulatory requirements. These standards help manufacturers design, produce, and maintain medical devices that are safe and effective for use. The standards are critical for gaining market access and maintaining compliance with regulatory authorities.
ISO 13485:2016 is an international standard that specifies the requirements for a quality management system (QMS) for the design, development, production, installation, and servicing of medical devices. It is applicable to organizations of all sizes and types involved in the medical device lifecycle.
The purpose of ISO 13485 is to ensure that medical devices consistently meet customer and regulatory requirements. The standard provides a framework for managing quality throughout the entire lifecycle of a medical device, from initial concept through production and post-market activities.
