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[INQ. NO. 2306E08] BODYFRIEND, Inc. recently announced that it has obtained ISO 13485 international standard certification from the global testing and certification body (BSI).
ISO 13485 certification is an international standard established by the International Organization for Standardization (ISO), and is a certification system that verifies whether the company has a management system and quality management system that meets international requirements, ranging from medical device development to production. It is drawing attention from companies that are trying to lead the globalization of domestic medical devices and development systems by receiving certification for the safety of medical devices.

Compared to other industries, certification procedures and acquisition in the medical field are more stringent. Among them, ISO 13485 certification can be obtained only when the conditions required by European countries with high standards are met. For this reason, companies that have received the certification are evaluated as having the qualifications to export medical devices to major countries around the world.
BODYFRIEND’s new medical device ‘Medical PHANTOM’ meets all of these certifications, and its outstanding feature is that it can be used for treating herniated discs and degenerative stenosis by towing the cervical and lumbar spine. Air is injected into an airbag that supports the neck and back, which expands and contracts repeatedly, pulling the lumbar and cervical vertebrae, thereby widening the gap between the vertebrae and alleviating the symptoms of disc and stenosis.
A spokesperson of the company explained, “Recently, to meet the growing demands of domestic and foreign consumers for healthcare medical devices, it is becoming more important to obtain internationally standardized medical device certification. So, we will accelerate the export of our healthcare medical devices to overseas markets based upon this international standard certification.”

 
 
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