Why you need ISO 13485 for your medical display manufacturing project

Welcome back again to Leadtek Display. I am Harriet.
Recently, we were audited & qualified to ISO 13485 , and we want to share with you what it is and what it means for you.

ISO 13485 is an international standard that specifies requirements for a quality management system (QMS) in the medical device industry. While ISO 13485 is not specific to medical display applications, but it plays a significant role in ensuring the quality, safety, and reliability in medical devices, including medical displays.

Here are some key reasons why ISO 13485 certification is valuable for customers in the display industry:

Quality Assurance：
ISO 13485 certification demonstrates that the manufacturer or supplier of medical display applications has implemented a robust quality management system.

This certification assures customers that the products they are purchasing meet stringent quality standards and comply with regulatory requirements.

Regulatory Compliance：
Medical display applications are subject to various regulatory requirements, such as those outlined by the U.S. Food and Drug Administration (FDA) or the European Medical Device Regulation (MDR).

ISO 13485 certification signifies that the manufacturer has established processes to comply with these regulations.

Product Safety and Performance：
Medical display applications are critical in healthcare settings, where accurate and precise visualization of medical images is essential for diagnosis, treatment, and patient care.

ISO 13485 certification ensures that the manufacturer follows best practices for design, manufacturing, and testing to deliver displays that are safe, reliable, and perform to the required specifications.

That's all for today, thank you for watching and see you next time

If you want to know more information, please click the video to watch thank you！