What is the difference between FDA 820 and 13485 ?

Title: What is the Difference between FDA 820 and 13485?

The healthcare industry is one of the most regulated industries in the world, and medical devices and equipment are no exception. Ensuring the safety, effectiveness, and quality of medical devices is critical for the well-being of patients. Two widely recognized standards for medical device quality management systems are FDA 820 and 1348While both standards aim to achieve these goals, there are significant differences between them. This article will explore the differences between FDA 820 and 13485 in detail.

What is the Difference between FDA 820 and 13485?

When it comes to regulations governing medical devices, two important standards that manufacturers and developers must abide by are FDA 820 and 1348Despite their similar objectives, there are several key differences between these two standards.

FDA 820: Quality System Regulation

FDA 820 is a standard for quality management systems that focuses on the overall management of an organization's medical device operations. It is intended to ensure that medical device manufacturers and developers have a comprehensive quality management system in place to consistently produce safe and effective medical devices.

FDA 13485: Medical Device Quality Management Systems

FDA 13485 is a companion standard to FDA 820 that specifically addresses the requirements for quality management systems for Class I medical devices. It is intended to provide guidance for manufacturers and developers to implement a quality management system for their Class I medical devices.

Key Differences between FDA 820 and 13485

While both standards are intended to ensure the quality of medical devices, there are significant differences between them. Here are some of the key differences:

Scope of Application

FDA 820 is applicable to all medical device manufacturers and developers, while FDA 13485 is only applicable to Class I medical devices.

Purpose

FDA 820 is intended to establish a comprehensive quality management system for medical device operations, while FDA 13485 is intended to provide guidance for implementing a quality management system for Class I medical devices.

Requirements

FDA 820 has more comprehensive requirements for quality management systems, including requirements for design, manufacturing, and testing. However, FDA 13485 has more specific requirements forClass I medical devices.

Responsibilities

FDA 820 assigns specific responsibilities for the management of medical device quality, including responsibility for design, manufacturing, and testing. However, FDA 13485 does not assign specific responsibilities for medical device quality management.

Format of Documentation

FDA 820 requires manufacturers and developers to maintain documentation that demonstrates their compliance with the standard. FDA 13485 does not require specific documentation format.

Conclusion

While both FDA 820 and 13485 are intended to ensure the quality of medical devices, there are significant differences between them. FDA 820 is a more comprehensive standard that applies to all medical device manufacturers and developers, while FDA 13485 is a more specific standard that applies to Class I medical devices. By understanding these differences, manufacturers and developers can ensure compliance with the relevant regulations and produce safe and effective medical devices.