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SWOT adheres to the highest standards for the manufacture of medical devices.

Our quality management system according to the ISO 13485:2003 is certified by TUV and pass the FDA inspection based on QSR 820.

Our medical devises meet the requirement of EU Medical Devices Directive MDD 93/42/EC and applicable standards.

ISO 13485:2003 - Design, Manufacture and Inspection of Medical Laser and Radio Frequency Devices. Certification by TUV against

FDA inspection


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