QUALITY CERTIFICATIONS

All Haemopharm products are CE marked, since safety is an essential value for the company. Moreover, the company daily gives its full attention to efficacy and quality of its production processes: the parameters of every system are constantly monitored by the proprietary software system for quality control, and all the procedures are UNI CEI EN ISO 13485:2012 and UNI EN ISO 9001:2008 certified.

Finally, the productive and analytical stages take place in a Clean Room and controlled environment in many classifications, in compliance with cGMP and with UNI EN ISO 14644-1-2-3-4-5-6-7 procedures, and are constantly verified with Audit Methods.

 

2012

ISO 9001:2008 of "Design and production of empty bags for parenteral, enteral nutrition and for cryopreservation. Production of empty bags for infusion solution and dialysis on customer specification. Design and manufacture of disposable devices and components for infusion and transfusion. Design and production of solutions for renal therapies, sterile wash solutions and for set for major auto-hemo infusion with ozone".»

2015

ISO 9001:2008 of "Design and production of empty bags for parenteral, enteral nutrition and for cryopreservation. Production of empty bags for infusion solution and dialysis on customer specification. Design and manufacture of disposable devices and components for infusion and transfusion. Design and production of solutions for renal therapies, sterile wash solutions and for set for major auto-hemo infusion with ozone".»

2016

ISO 13485:2003 of "Design and production of empty bags for cryopreservation, enteral/parenteral nutrition, collection and drainage; of medical devices for infusion and transfusion and set for auto-haemo infusione with ozone. Design and production of solutions for dialysis, irrigation, washing and instillation therapy. Production on specific of the customer of empty bags for infusion and/or dialysis".»

 

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