ISO 13485

The regulation of medical devices continues to grow globally each year. And, while the name may seem confusing, ISO 13485 is the current standard for the design and manufacture of medical devices, including ultrasound systems. The only way to obtain this certification is to pass a third-party Medical Device Single Audit Program (MDSAP) audit. But what exactly is ISO 13485 and what does it mean for Advanced Ultrasound Electronics clients?

The International Organization for Standardization (ISO) functions as an independent, non-governmental international organization that strives to help organizations become better in nearly every industry including technology, agriculture, food safety and healthcare. Currently, they have amassed an impressive 23302 unique international standards that span these different industries through the support of 165 unique members representing the ISO in their own country.

What is ISO 13485?

Although information commonly found on ISO 13485 may make it seem like an abstract concept for the average person, it is considered the main Quality Management System (QMS) standard for nearly all medical devices. However, there may be some variation in this standard from as several countries have set their own regulations. For instance, in the United States, ISO 13485 is certified in conjunction with FDA requirements set forth for medical devices.

While most people will likely think that ISO 13485 is given as a certification for individual products, that simply is not true. Instead, ISO 13485 is a process-based standard that can be used to help define the manufacturing processes that ensure an end product meets the desired results needed to maintain certification or implement a relevant quality management system into their processes. Once an audit has been completed to ensure their organization adheres to the latest ISO 13485 requirements, they then receive a certification demonstrating their adherence to their guidelines that remains effective for 3 years.

As you might imagine, the guidelines used for ISO certification are updated regularly and a new audit is required every three years to maintain an ISO 13485 certification status. At the current time, the newest version of ISO 13485 was released in March 2016. As standards continue to evolve and change, manufacturers of medical equipment need to adhere to ISO certification standards and refine their manufacturing processes to improve the devices that they can provide to the public safely.

What Does ISO 13485 Mean for our Clients?

As a major repair facility in the ultrasound industry, Advanced Ultrasound Electronics has obtained ISO 13485 certification to help elevate our repair standards and processes. This allows us to make certain that all refurbished items that leave our facilities are thoroughly tested and restored before our clients receive them. This extra commitment to ensuring we deliver the highest quality products available for medical practices or health organizations makes us a clear partner when you need repair services on your ultrasound systems.

While it is no surprise that ISO 13485 is common among equipment manufacturers, it is much rarer for smaller independent service organizations, particularly for those that are the size of Advanced Ultrasound Electronics. This is a unique distinction that sets AUE apart from other service providers or refurbished ultrasound system dealers because customers can rest easy knowing they are partnering with a certified and reliable organization for their retail needs as well as any extended assistance or repairs that may be needed in the future. Each product that leaves our facility follows the same processes that are required for ISO 13485 certification and is tested for accurate functionality before leaving the premises.

At Advanced Ultrasound Electronics, we strive to not only provide our clients with reliable ultrasound systems from a variety of the top brands available but also want to ensure they are receiving devices that are safe and effective. By also partnering with brands that have obtained ISO 13485 certification, we can provide our clients with consistently high-quality ultrasound equipment that can be used in their practice. This not only ensures proper readings when the equipment is used, but it also ensures that they are investing in high-quality products that they can trust for years to come.

Why Partner with Advanced Ultrasound Electronics?

If you need new ultrasound systems or need repairs on your existing equipment, the team at Advanced Care Ultrasound is here to help. We have invested heavily in our facility and have one of the most extensive new and refurbished parts, probes, and systems inventory in the business. Visit our website at or call us at (866) 620-2831.

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