Bodyfriend Acquires 'ISO 13485' International Standard Certification

Medical Device Quality Management System
Obtained International Standard Certification 'ISO 13485'
Specialized Management System for Medical Device Industry

Healthcare company Bodyfriend announced on the 23rd that it recently obtained the international standard certification ‘ISO 13485:2016 & EN ISO 13485:2016 (hereinafter ISO 13485)’ for medical device quality management systems from the global testing and certification body BSI. The ‘ISO 13485’ certification is an international standard established by the International Organization for Standardization (ISO). It is a certification system that verifies whether a company has a management system and quality control system that meet international requirements from the development to the production of medical devices.

The medical field has more stringent certification procedures and acquisition requirements compared to other industries. Among them, the ‘ISO 13485’ certification can only be obtained by meeting the conditions required by European countries with high standards. Companies that receive this certification are recognized as qualified to export medical devices to major countries worldwide.

Through this certification, Bodyfriend was deemed suitable in the operation of systems related to the development, production, distribution, and service of medical devices developed through R&D investment. In particular, the new product ‘Medical Phantom’ meets all these certification requirements. Its most notable feature is that it can treat cervical and lumbar traction to address herniated discs and degenerative stenosis.

A Bodyfriend representative stated, “As the demand for healthcare medical devices from domestic and international consumers grows, obtaining internationally standardized medical device certification is becoming increasingly important,” adding, “We will use this international standard certification as a stepping stone to accelerate Bodyfriend’s overseas expansion of healthcare medical devices.”

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