The importance of being ISO 13485 Certified

The importance of being ISO 13485 Certified

When buying medical devices for home use, there is a certification you can look out for to have peace of mind that what you’re buying is of high quality and safe. This is the ISO 13485 certification that Koite Health has received for its antibacterial dental devices: Lumoral. 


What is ISO 13485


Before we dive into the specifics, ISO stands for International Organization for Standardization. It is an organisation dedicated to developing voluntary standards that will guarantee product safety and quality. The ISO also encourages innovation in the global marketplace. 


The ISO 13485 certification is given to organisations that demonstrate its ability to provide quality medical devices and related services. To qualify for this certification, one must consistently meet customer and other applicable regulatory requirements. 


ISO 13485 is an absolute requirement for the production of medical devices and equipment. This certification guarantees that all tools, procedures, and processes of the manufacturing company comply with medical services regulations.


The importance of ISO 13485 certification


Safety and quality guaranteed


As mentioned earlier, if a medical device is ISO 13485 certified, you can be assured that the maximum product safety and quality control protocols have been followed throughout the product’s full life cycle. This includes subcontractor operations.


Product consistency and continuous improvement


When a manufacturer is ISO-certified, consistency in terms of quality is guaranteed. Not only that, one of ISO principles ensures that a certified organisation continues to evolve for the better. Manufacturers with this ISO certification are always on the lookout on how to improve their processes so they can reduce problems along the way and have more time delivering products and services that are of high quality.


ISO 13485-certified dental hygiene device for home use


Koite Health has a ISO 13485 certification for Lumoral, an antibacterial medical device for home use which helps prevent oral diseases and bacterial infections.


The certification guarantees that Koite Health is a designer, producer and manufacturer of quality and safe medical devices. It also strengthens the role of Koite Health as a product development partner for international business in the medical device and pharmaceutical space.


The certification is granted by SGS, the world’s leading inspection, verification, testing and certification company.


What is Lumoral?


Lumoral is a technical mouthwash solution that kills even microscopic plaque bacteria in the mouth. This device can be purchased online and be easily used at home. 


This medical device is particularly effective against Streptococcus mutans, bacteria known to play a more prominent role in the worsening of caries and periodontitis.


The major benefit of this light activatable technical mouthwash over regular mouthwashes is the accuracy and superior antibacterial strength upon light activation. Where normal mouthwashes affect the whole oral microbiome, the technical mouthwash only targets those bacteria in dental plaque leaving the rest of the oral microbiome in peace.  


The accuracy of Lumoral method makes it ideal for continuous use for preventing oral diseases without the worry of negative side-effects that are associated with other antibacterial home use methods such as chlorhexidine mouthwashes. 

Use Lumoral twice a week for a healthier mouth

Take your oral hygiene to a new level with the most effective mouth rinse on the market. This ISO-certified light-activated device is a safe, proven and easy to use method for improved oral health. 

Regular use of Lumoral can help prevent gum inflammation. It eliminates unhealthy bacteria causing tooth decay while supporting healthy flora and gum health.

Use Lumoral twice a week before brushing your teeth for improved dental hygiene and healthy gums. Get one now and enjoy free delivery Australia-wide.

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