How Our ISO 13485 Certification Can Transform Your Medical Devices

Planning at Every Step for Safe, Effective Design

Ezurio strives for excellence in product design, from the moment a schematic is begun to the end of a 15 year end product life cycle. There’s a lot to think about: optimal electronic design, materials design, regulatory compliance, co-existence with other devices, long term security concerns, and much more. One of the ways companies do this is by having a well-documented quality management system (QMS) and adhering to those practices at every step of the process.

In many industries, one of the most common QMS systems is ISO 9001. It’s a standard that helps organizations ensure their quality standards are minimally viable to meet customer expectations and yield quality results. This standard covers all functions of the business that contribute to the final product and is driven by 7 quality management principles: customer focus, leadership, engagement of people, process approach, improvement, evidence-based decision making, and relationship management.  

ISO 9001 is widely adopted among reputable companies, not just as a way to check boxes for compliance but also to drive the success of their businesses. Standards like this work, in terms of helping companies best serve customers and to produce a better business that delivers better on its objectives. ISO 9001 serves companies across multiple industries and categories of business.

For medical applications, an even more stringent standard exists to ensure quality management systems meet the uniquely sensitive requirements of this industry. That standard is ISO 13485, and it uniquely focuses on the aspects of quality management that have the greatest impact on patient safety, regulatory compliance, and risk management. For manufacturers of Connected SOMs, this certification is more than a best practice – it’s a business necessity.

Recently, Ezurio’s US-based manufacturing facility (located in Irvine, CA)secured ISO 13485:2016 compliance for our quality management system. This manufacturing facility builds system on modules (SOMs) and single board computers (SBCs)that form the basis of many products, including those intended for medical markets. In this post, we’ll have a look at what ISO 13485 means for our business and for our customers, and some of the benefits of having a US-based ISO 13485 manufacturer.

Why ISO 13485 Matters for Connected SOMs

It’s important to note that ISO 13485 is created by building further upon the already world-recognized value of the ISO 9001 standard. It builds upon that in ways that are directly tied to patient security requirements and are in close alignment with requirements of regulatory bodies like the FDA. What this means is that quality and compliance are baked into the process at every turn, rather than trying to demonstrate compliance after the fact.

Some of the key differences between ISO 13485 and ISO 9001 include the following:

• Because it’s geared toward medical applications (which have much more stringent compliance requirements than many others), ISO 13485 expands greatly on the QMS elements that are related to regulatory compliance. This means those processes are rigorous and documented to prove traceability throughout the development cycle and OEMs can demonstrate this to regulators. 
• There is also a greater emphasis on risk management, requiring a business to document and proactively consider potential risks and keep records of them throughout device production. This expands on traditional ISO 9001 risk management assessment, which encourages businesses to have a comprehensive understanding of risk, undergo strategic decision-making, and ultimately fosters customer trust and reliability. ISO 13485 requires a higher level of detail, to the ultimate goal of producing safer and more reliable products where health is on the line. 
• All aspects of designing and realizing a product undergo higher scrutiny in ISO 13485. There are specific standards outlined everywhere from the design phase through to testing and validation, and in manufacturing as well. These are tied to the requirements of the regulatory body and to the demands of medical treatment. By following ISO 14385 standards, devices can have a much higher standard of quality and reliability all the way from the first bits of design. 
• In medical devices, it’s even more critical to have a keen eye on supply chain management. While missing or unavailable components can have a detrimental effect on products like consumer goods, that effect becomes a matter of public health in medical devices. This is why ISO 13485 requires manufacturers to more rigorously determine and document procedures for selecting suppliers, qualification of materials, and continuous validation of those procedures. Those procedures must be regularly evaluated and audited to avoid unexpected disruptions to the supply chain in these critical devices. 

These are the major areas of focus in ISO 13485, tailored not just in their specificity and detail, but also to the areas of focus that make the best medical products. By preparing for potential risks and failures and rigorously documenting their planning and procedures, businesses like Ezurio ensure that they can reliably and safely guarantee a continuous supply of world-class medical products.

US-Based Manufacturing with ISO 13485 Is a Natural Fit

In addition to all the previously mentioned benefits of ISO 13485 certification, one more benefit is the particular alignment of ISO 13485 and the FDA. ISO 13485 enforces thought processes and procedures that are useful in acquiring certification in many places around the world. But the standard is particularly aligned with the US Food and Drug Administration. This means that for those designing medical devices for use in the US, choosing a hardware supplier who has ISO 13485 certification is especially expedient.

No regulatory area is more scrutinized than the medical device market, and for good reason. Device failures in the medical environment mean everything from the disclosure of private patient data to the complete malfunction of critical treatment. Securing regulatory approval for medical devices, from concept to market, averages anywhere from 3 to 7 years. Choosing a hardware supplier who has a proven track record with the FDA and who has the ISO 13485 certification bodes very well for reducing time to approval for device makers.

Additionally, today’s geopolitical environment places a renewed emphasis on reliable supply chains and domestic manufacturing. Supply chain disruptions, trade tensions, and national security concerns all make a strong argument for US-based manufacturing, especially in critical fields like medical. Choosing an ISO 13485-certified US-based manufacturer provides a greater reliability of supply chain resilience, regulatory compliance, and security / IP protection. In combination with Ezurio’s recent changes to our country of origin strategy, this insulates customers from some of the greater risks associated with supply of critical components.

“Achieving ISO 13485 certification is more than just a milestone—it’s a reflection of Ezurio’s commitment to the highest standards of quality, safety, and regulatory excellence in medical device manufacturing. By embedding these rigorous standards into our US-based operations, we help our customers accelerate time to market, mitigate risk, and confidently deliver life-critical devices that patients and healthcare providers can trust.”
— Jason Stoddard, VP of Global Operations, Ezurio

Taking the Thousand Foot View for Medical Devices

Ezurio’s work to secure ISO 13485 compliance is just the latest of our many moves to best position our customers for success. Nowhere is more critical to provide that assistance than in the medical device arena, and our certification lends customers confidence that medical devices based on our SOMs and SBCs can comfortably secure regulatory compliance and will be reliably supplied, secured, serviced, and supported throughout the long life cycle of a medical device.

Ezurio provides a wide range of certified and tested devices (see this post on our reliability testing) that give OEMs design flexibility, reliability, long term support, and a trusted platform for wireless and compute. For more on our line of System-on-Modules and SBCs, please visit our website:

https://www.ezurio.com/system-on-module

https://www.ezurio.com/single-board-computer