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International Standards for Medical Devices

August 12, 2019

 

At Southwest, we believe that it is our job to equip you with the equipment you need to provide your patients with outstanding patient care. This is why we hold ourselves to the objective standards of ISO 13485. To learn more about what that means, and why it matters for you, continue reading.

 

 

From food products to children’s car seats, international standards exist to ensure quality and consistency, maintain the global market, and create clear benchmarks for companies of all sizes and services.
 
The International Organization for Standardization (ISO) is one such organization that is helping to uphold global standards for a range of industries and products or management systems. This non-governmental body “brings together experts to share knowledge and develop voluntary, consensus-based, market relevant International Standards” (
All About ISO).
 
Why do these standards matter? Because not all management systems, manufacturing processes, or documentation procedures are subject to a regulatory body that can promise this kind of quality assurance. In a sales-focused economy, companies make promises to their customers and it’s imperative that a standard exists to ensure those promises are being met.


 
How to Read International Standards
 
International Standards can be broken down into three parts: The issuing organization, the standard code itself, and the year it was last revised.
 
For example, ISO 13845:2016 refers to the medical device standard issued by ISO and revised in 2016.
 
A country may adopt an international standard, whereupon it is adapted to meet certain requirements or regulations of that country. In the US, this standards organization is called the American National Standards Institute (ANSI). ANSI, along with the sub-organization the Advancement of Medical Instrumentation (AAMI), has adopted the ISO 13845:2016 standard and applied it to businesses within our country. For this reason, you may also see the standard written as: ANSI/AAMI/ISO 13485:2016.
 
Think of it as a triple assurance that the certification of this standard meets the requirements of three regulatory bodies.
 
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International Standards for Medical Devices
 
Safety and quality are imperatives in the medical devices industry as they can truly be matters of life and death. Thus, there are regulatory requirements for not just medical devices themselves, but for every step, product, and documentation in a device’s life cycle. Developers and manufacturers in our industry must be able to demonstrate their quality management processes and the best way to do this is through certification by international standards.
 
At a global level, both the International Organization for Standardization (ISO) and the
International Electrotechnical Commission (IEC) issue international standards for the medical device industry.
 
IEC 60601 focuses more on technical safety and effectiveness standards, while ISO 13485 establishes the requirements for a quality management system for both the design and manufacture of medical devices. The two bodies will cooperate with each other, when appropriate, to ensure standards are congruent.
 
ISO 13485 covers aspects including risk management, design control during product development, and verification and validation systems. At SwMR, all of our equipment, installation, and servicing of medical devices is certified by this international standard.
 
ISO 13485 was revised in 2016 as part of a routine 5-year review for all ISO standards. In this latest edition, there is greater emphasis on risk management and risk-based decision making, as well as changes related to new technology and to the increased regulatory requirements for organizations in the supply chain.
 
The Importance of Certification
 
Being certified to a standard is not a requirement, and there are many benefits reaped from simply implementing the standard without undergoing the certification process. However, third-party certification can demonstrate to regulators, consumers, and even competitors that a company has met the requirements of the standard.
 
Certification to ISO 13485 and other International Standards not only delivers peace of mind to consumers within the medical device industry, but it also helps companies like ours by providing a blueprint for maintaining excellent quality assurance.
 
Interested in Teaming Up with an ISO Certified Company?
 
Southwest Medical Resources provides turnkey solutions for your GE MRI, CT and PET/CT equipment needs. We do upgrades, fully-customized solutions from suite build-outs to mobile remanufacturing, and offer Interim rentals or multi-year lease agreements. Whatever your unique needs may be,
make SwMR your strategic partner. 

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