ISO 13485 is an international standard focused on Quality Management Systems (QMS) for medical devices.

It provides a framework for organizations to ensure that their medical devices consistently meet customer and regulatory requirements. The standard is important for companies involved in the design, production, installation, and servicing of medical devices.

The ISO 13485 Standard emphasizes a systematic approach to managing quality throughout the lifecycle of medical devices. It covers various aspects, including risk management, design control, and the need for effective documentation and record-keeping. Compliance with ISO 13485 helps organizations demonstrate their ability to produce safe and effective medical devices.

ISO 13485 Requirements include several key elements. First, organizations must establish and maintain a quality management system that aligns with the specific needs of the medical device industry. This involves defining quality objectives, planning processes, and conducting regular audits to ensure compliance. The standard also requires rigorous control over the design and development process, supplier management, and post-market surveillance.

One of the strengths of ISO 13485 is its focus on regulatory compliance. The standard is designed to be compatible with various regulatory requirements worldwide, making it easier for organizations to navigate global markets. It is intended to be integrated into the organization's existing management systems to enhance overall quality and regulatory adherence.

For further details about ISO 13485, you can visit the official website of the International Organization for Standardization (ISO) here: ISO 13485 - Medical Devices Quality Management Systems.