Polyganics' quality system complies to ISO 13485, and dictates quality management standards and requirements for a comprehensive management system for design, manufacturing and distribution of medical devices. Polyganics also intends to comply with the USA FDA 21 CFR 820 corresponding subparts. The Polyganics' Quality Management System is ISO13485:2003 certified by Dekra Certification BV.
|European market||Device class: Class III|
|EC Notified Body||Identification number: 0344|
Device Class 2; FDA 510(k) number:
K032115 (1,5 - 3mm)
|Regulation number||21 CFR 882.5275|
|Establishment registration number||3004504732|