Quality
Quality for Life
Operating in a socially crucial field like healthcare, Eurospital stands out for its dedication to implementing internal processes that ensure quality and safety for customers, patients, and consumers — as well as for suppliers, distributors, and stakeholders in the medical-scientific community.
This ongoing commitment has not only ensured high-quality products and reliable services, but has also strengthened Eurospital’s reputation over the years as a trusted partner.
Our commitment has been officially recognized since 1995 with the certification of Eurospital’s Quality Management System across all business areas, in accordance with European and international standards.
Certifications
Eurospital’s Quality Management System is certified in accordance with UNI EN ISO 9001:2015 and EN ISO 13485:2016 standards. In 2017, Eurospital became the first company in the sector in Italy to receive certification from TÜV America under the Medical Device Single Audit Program (MDSAP). This program, promoted by the regulatory authorities of four countries (Brazil, Canada, Japan, and the USA), allows a single audit to assess compliance with ISO 13485:2016 and the specific regulatory requirements of each participating country, for a manufacturer’s Quality Management System covering medical and in vitro diagnostic devices.
Additionally, in 2022, Eurospital was among the first Italian companies to comply with the new In Vitro Diagnostic Regulation (IVDR) and to obtain the EU Quality Management System Certificate (IVDR) for its devices from the international body TÜV SÜD, further confirming its commitment to meeting the highest European and international standards.
Download Documents
“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 N. Q5 066267 0027 Rev. 03”
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.