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Quality Assurance

Quality Control
Having an up-to-date infrastructure and leading-edge technologies, we supply only acceptable products to our customers using a production process that complies with International Quality Control Standards (ISO 13485) and conforms to strict internal quality standards.


2006: Acquisition of ISO 13485 & ISO 9001 and FDA marketing clearance for Mytis Arrow Implant System (K052254) 2007: Acquisition of FDA marketing clearance for β-POWDER (K063236) 2009: Acquisition of FDA marketing clearance for ArrowBone- β (K083372) ISO 13485


According to the codes of GQP/QMS, manufacturing and quality controls are practiced in our plants and at authorized certified outside manufacturers, whereas quality assurance and safety control according to the codes of GQP/GVP are exercised for our manufacturing and sales business.


GVP (Good Vigilance Practice)
FDA K052254
FDA K063236
FDA K083372

Regarding all products relating to our company, we strictly monitor post marketing product safety and continuously collect safety control information.


A label for medical recording Every Mytis Arrow Implant is supplied with the label for medical recording. It can be affixed postoperatively to the patient’s medical record or clinical treatment chart to record the lot number.

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