Authorization ISO

ISO Ambiente 14001:2015

ISO 9001:2015

ISO 13485:2016

Authorization CE

CE Organ Preservation

CE Concentred Hemodialysis

CE Empty Bottles Sterile

CE Irrigation and Washing

CE Surgical Marking

CE Liquid Paraffin

CE Renal Therapies

CE Treatment of Blood

FDA Authorization

510k FDA Consulting Medical Device Clearance – SERVATOR H

510k FDA Consulting Medical Device Clearance – SERVATOR B

510k FDA Consulting Medical Device Clearance – SERVATOR C

General Authorization GMP

Manufacturing authorization aM-108-2014

GMP Human 06/09/2019

GMP Veterinary 09-01-2018

Environment Reports

Environment Report 2015 SALF (Italian)

S.A.L.F has obtained the MDSAP registration certificate

Promoted by the Regulatory Authorities of 5 different countries (Australia, Brazil, Canada, Japan and the United States of America), MDSAP (Medical Device Single Audit Program) is a program that allows accredited organizations (Auditing Organizations – AO) to conduct a single audit of medical device manufacturers to ascertain that they meet the quality system management requirements (GMP: Good Manufacturing Practice) of all reference countries.

The achievement of the MDSAP registration certificate, attests that Salf designs and produces MDs according to high quality standards in compliance with European, American, Japanese, Canadian and Australian regulations.