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Life or Death in the Medical Industry – ISO 13485 Matters!

Julia Shih 0

A few months ago, we at AMAX proudly announced that we added the very-selective ISO: 13485: 2003 certification to our lineup of ISO manufacturing certificates. This certification is specific to the designing and manufacturing of medical devices, and is widely known within the manufacturing industry as the most rigorously stringent certification representing the highest standard of quality a company can achieve.

So what is ISO 13485?

ISO 13485 is an International Organization for Standardization (ISO) standard, published in 2003, that represents the requirements for a comprehensive quality management system for the design, development, manufacturing, distribution, sales, technical support and service in support of the medical device industry.

It demonstrates that AMAX has successfully implemented a quality management system that conforms to the world-wide standard for medical device and diagnostic manufacturing. Since we specifically manufacture x86-based server appliances and rack-level data center/cloud solutions for the medical industry, the certification covers servers that are used as “medical device accessories,” which operate as the computing, storage and cloud components connected to medical devices in the field.

Why does ISO 13485 matter?

Industries in which these servers can be found include Biotech, Hospitals and Medical Centers, Therapeutics, Pharmaceuticals and Scientific Research, even in Universities/Colleges that offer medical courses. Usages include patient management systems, medical records, medical device data processing, compiling and archiving, as well as high-tech surgical equipment.

The manufacturing requirements met by AMAX’s ISO 13485 certification entail that all server equipment manufactured by AMAX meet the highest standards to ensure the lowest possibility of manufacturing error and field failures, so medical customers can have the peace of mind knowing their equipment will not fail or malfunction in the field. Due to the often life and death nature of operations in the medical industry and the importance of the data that is routinely handled, this is a risk the medical industry simply cannot take.

To further strengthen what AMAX offers our customers in the medical industry, we strongly comply with our official Quality Policy: To improve the quality and length of human life by commercializing technologies that provide substantial value to our customers with superior quality products & services. We achieve this by:
• Proactively soliciting input & feedback from our customers
• Measuring customer satisfaction, and
• Continuously improving our processes, products and services while maintaining an effective Quality Management System in compliance with Regulatory & Statutory requirements.

Medical Device Component Servers in the Field

AMAX has supported clients in the medical device industry by manufacturing, testing and deploying complete turnkey systems that are fully compliant with FDA regulations, resolving any concerns regarding safety or reliability. AMAX’s servers are used by hospitals to treat patients, and have helped our clients increase revenue and reduce overhead costs due not only to AMAX’s quality-oriented manufacturing processes which increase reliability and optimize field performance, but by developing the solutions on platforms offering the longest technology life cycle. To read a full case study, please click here.

AMAX’s ISO 13485 certification continues our tradition of striving towards the highest standard of manufacturing excellence, joining previously-attained ISO 9001 (quality manufacturing) and ISO 14001 (environmentally green) certifications. Not only does high manufacturing standards towards quality provide the best TVO (total value of ownership) by guaranteeing the best field performance and uptime while reducing costs related to maintenance and repair, but when people trust your company’s products with their lives, it is the underlying quality of your components that will make sure that your brand delivers.

Are you a medical company offering cutting-edge medical equipment? Is your server manufacturer ISO 13485 certified? To find out more, please visit