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 complies to 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:
|Regulation number||21 CFR 878.3300|
|Medical Specialty||General and Plastic Surgery|
|Establishment registration number||3004504732|