ISO 13485 – practical solution for medical devices

Today’s medicine is evolving quicker than it ever was. With the emergence of new diseases and all the new ways they can spread across the world, it is necessary that there are worldwide requirements put on all medical devices if we want to have any chance of winning.

There are so many regulations to be met though, classic paperwork and making sure every device is compliant with the newest ISO 13485 requirements manually becomes nearly impossible. The margins for error are very slim and the stakes are higher than ever.

What could possibly save all medical devices manufacturers their precious time, money and allow them to distribute their product with no bumps along the way? ISO 13485 software – the only practical solution for medical devices in the modern, highly-technological world.


What does it do?

ISO 13485 software helps companies and manufacturers comply to all the demanding needs of the regulations set by the International Organisation for Standardisation. It provides means to manage documents and all processes that are a part of the manufacturing and distribution process, including risks, audits, non-conformances, customer complaints, product data to name a few. It also help to control the design of the devices and the software they operate on.

There is no room for error here – one little device failure could cost someone a life. Still, some companies seem to think that ISO 13485 software is just an unnecessary purchase.



Why is it practical to switch to ISO 13485 software?

Relying on outdated spreadsheet-based and paper-based systems is risky and can lead to many costly mistakes. The medical industry is highly regulated. Such paper instructions and documents would have to be updated almost daily. Aside from the inefficiency that this would bring, added costs and negative impacts on productivity have to be taken into consideration as well. Medical device manufacturers need solutions as agile as their operations. Only high quality software is able to give them that. You can learn more on – software house’s website dedicated to large companies

Any ISO 13485 software available on the market right now is better than flicking through countless pages of constantly changing, tight and challenging requirements.  ISO 13485 regulations contain a variety of exclusions and minute details which must be identified and strictly followed to keep a device compliant with the latest standards. Thus, quality management must give the manufacturer the ability to coordinate all applicable sections of ISO 13485. Thanks to a handy software solutions it gets easier and easier. There is no reason to stick to the good old methods if they prove inefficient. Technology is here to stay – we may as well trust it and use it to our advantage.


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