The medical device industry is one of the most heavily scrutinized and regulation-driven in the world. Regulatory challenges expand beyond the most sophisticated markets: Although the U.S. accounts for about 40% of the global market and Europe about 30%, high quality standards prevail in smaller blocs and nations as well.
With an estimated 500,000 distinct medical technologies available globally, it is no surprise there is a driving need for exceptional quality and consistency across national borders. The ISO – International Organization for Standardization – is a driving force in defining global standards.
Why the ISO Stands Alone in Setting the Gold Standard for Medical Device Quality
Much is said about the ISO in the context of modern medical devices and its landmark quality management standard, ISO 13485. However, the ISO’s reach and influence extend well beyond this industry. Its unique ability to harness global standardization expertise is known worldwide.
The International Organization for Standardization – the term “ISO” comes from the Greek word meaning equal – was founded in 1946. In the wake of World War II, its mandate was to bring together the world’s top engineering experts to coordinate standards to the benefit of all.
More than 160 countries and nearly 800 distinct technical bodies contribute to the ongoing work of the ISO. It has published more than 21,000 International Standards covering a vast spectrum of technology and engineering topics crucial to effective collaboration in our fast-moving world.
In addition to manufacturing quality, its work touches on vital subjects like telecommunications, finance, and information security. Developing a final International Standard is an exhaustive and often years-long process relying on hundreds of industry-leading experts and many drafts.
With this in mind, ISO is alone in its unique capability to devise the highest global quality benchmarks.
Even the world’s most advanced economies enthusiastically accept and adopt ISO standards. They have stood practically alone in helping enterprises that aspire to global thought leadership deliver the highest quality of service to customers and foster trust with regulators.
In an industry where regulatory overhead increases regularly – thus becoming one of the main drivers of cost – ISO standards and ISO 13485 in particular stand out for their potential to help businesses throughout the medical device supply chain arrest costs and expand quality.
ISO 13485 is a Unique Global Emblem of Medical Device Quality and Commitment
ISO 13485 is a comprehensive standard covering quality management within the medical device industry. It defines the requirements for stakeholders in medical device manufacture, distribution, and support to set internal controls and processes governing quality and safety.
Reflecting the unique centrality of safety in medical device industry operations, ISO 13485 takes a comprehensive view of the complete product lifecycle. It empowers principals in development of medical devices to take control of quality throughout their entire supply chain.
There is, simply, no other international standard like it – nor are there any on the horizon.
Although medical device markets maintain their own strict standards, ISO 13485 can serve as the keystone for any organization wishing to streamline the process of meeting such requirements. This accelerates commercialization and simplifies thousands of standards down to a handful.
Technosoft Innovations adheres strictly to ISO 13485 in everything we do, internally and with clients.
Our tireless efforts on both quality and safety include rigorous implementation of all elements of ISO 13485. Throughout our matrix organization of cross-functional medical device experts, ISO 13485 is a way of life. Third-party certification to the ISO 13485 standard includes demanding requirements in continuing education and ongoing audits that we readily embrace.
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