The Degania Medical companies have the following certification:

Degania Silicone Ltd.	ISO   9001 : 2008 ISO 13485 : 2003 ISO 14001 : 2004 CE : MDD 93/42/EEC FDA 510(k) US Marketing Clearance	Download PDF
Arthesys SAS	ISO   9001 : 2008 ISO 13485 : 2003 CE : MDD 93/42/EEC	Download PDF
Degania Medical Devices Pvt. Ltd.	ISO   9001 : 2008 ISO 13485 : 2003	Download PDF

All manufacturing is carried out in accordance with CGMP guidelines.