The Need for Standardization, Especially in ISO 13485 Medical Devices

The first step in achieving permission to sell high quality medical devices in the European Union is in ISO 13485 Medical Devices standard certification. An extremely advantageous service to use is that of an ISO 13485 consultant who can help you define the regulations, identify and analyze the appropriate measures that need to be taken for your business, and advise on implementation and training to maintain those standards. But why is there a basic need for international standardization in the first place? Why is it important for countries all over the world to conform to these standards?

Well, the ISO pertains to many industrial and commercial areas for a reason. We take for granted how many tools or systems we use that translate across countries. Punching holes into paper is one example. The ISO determined the exact diameter for those holes, the exact location of the holes from the margin and established three standards for hole punching: one internationally, one for North America, and one for Sweden. And now we most likely never come across a piece of paper whose holes don’t line up with the rings of a binder, and we never imagine that we could.

Of course, with the ISO 13485 for medical devices, the standardization for tools becomes much more vital. An incorrect hole punch is inconvenient, but not detrimental. It’s important for different countries to all maintain one standard for their medical devices, whatever they may be – instruments, implants, or machines. Otherwise, if different countries had different standards, there could be very serious and harmful results. Besides the obvious critical reasons, it’s also logical in a business sense. With certification, manufacturers can choose to take their companies international, as they are now able meeting the standards expected across the world.

And the ISO doesn’t just work with standardizing tools, there are regulations set in place that universally establish country codes, safety labels, standard atmosphere, programming language and hundreds more. While we live in a world that appreciates diversity in culture by enjoying the foods, clothing, and specialties of different countries, there are a lot of times where it makes sense to all speak the same language and have the same requirements. Medical devices are one very important case. To speak with an experienced ISO 13485 Medical Devices Standard consultant on how to plan and implement procedures to attain certification, contact David Owen Associates.