HDH Medical

Regulatory and QA

Full Quality Assurance certification (‎ISO 9001:2008, ISO 13485:2003, CAN/CSA ISO 13485:2003) has been obtained for the "design, manufacturing, sales and distribution of medical devices for open and laparoscopic vascular procedures". 

CE audit was done by DEKRA Certification as Notified Body, and the CE Certificate was received in June 2009 for B.Y.Fix product line and in February 2013 for Vacular Grafts.
Local certifications obtained in Israel, Italy and Canada.
Certification in progress in other countries.


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CE Certificate B.Y.Fix Device

CE Certificate-B.Y.Fix Prostheses
CAN ISO13485 certificate
ISO 13485 and 9001certificate
Free Sale Certificate