Quality
Quality for life
The healthcare industry is extremely demanding when it comes to the quality of the products and services to ensure confidence and safety.
Our commitment was acknowledged the first time in 1995, when we received the Eurospital Quality System Certification for all the company’s sectors in compliance with European and international standards.
Today, Eurospital is certified in compliance with the following standards: UNI EN ISO 9001:2008, EN ISO 13485:2012, and ISO 13485:2003 within the MDSAP (Medical Device Single Audit Program).
MDSAP is an international program that allows the conduct of a single regulatory audit of a medical device manufacturer’s quality management system that satisfies the relevant requirements of the regulatory authorities participating in the program.
In 2017, Eurospital was the first healthcare company in Italy to obtain the TÜV America certification for the US and Canadian markets.
To consolidate its commitment to comply with the highest European and international standards, in April 2022 Eurospital is among the first Italian companies to adapt to the new In Vitro Diagnostic Regulation and to obtain the “EU Quality Management System Certificate (IVDR)” for in vitro diagnostic medical devices by the international notified body TÜV SÜD.
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“CERTIFICATE Nr. 50 100 8039 – Rev.08”
This is to certify that the quality system of EUROSPITAL S.p.A., registered office and operational site Via Flavia 122 I-34147 Trieste (TS) has been found to comply with the requirements of UNI EN ISO 9001:2015.
“CERTIFICATE Nr. 066267 0028 Rev.02”
Design and Development, Manufacturing and Distribution In-Vitro Diagnostic Medical Devices, including Self-Testing, for Diagnosis of Autoimmune, Diseases, Coeliac Disease, System Infections, Inflammatory Bowel Disease ISO 13485:2016.
“CERTIFICATE N. Q5 066267 0027 Rev. 02”
EN ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016) DIN EN ISO 13485:2016.
“CERTIFICATE N. QS6 066267 0028 Rev. 03”
Design and Development, Manufacturing and Distribution In-Vitro Diagnostic Medical Devices, including Self-Testing, for Diagnosis of Autoimmune, Diseases, Coeliac Disease, System Infections, Inflammatory Bowel Disease ISO 13485:2016.
“CERTIFICATE V12 066267 0034 – Rev.00”
The Certification Body of TÜV SÜD Product Service GmbH certifies that the manufacturer has established, documented and implemented a quality management system as described in Article 10 (8) of the Regulation (EU) 2017/746 on in Vitro Diagnostic Medical Devices.