Authorization
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.