{"id":5096,"date":"2024-08-19T17:55:36","date_gmt":"2024-08-19T15:55:36","guid":{"rendered":"https:\/\/www.eurosets.com\/?page_id=5096"},"modified":"2024-11-19T11:36:04","modified_gmt":"2024-11-19T10:36:04","slug":"ra-qa","status":"publish","type":"page","link":"https:\/\/www.eurosets.com\/en\/ra-qa\/","title":{"rendered":"RA & QA"},"content":{"rendered":"\t\t
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RA & QA<\/b><\/h1>\t\t\t\t<\/div>\n\t\t\t\t
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EUROSETS established a Quality Management System that integrates compliance with Medical Devices standards and regulations to ensure the quality, safety, and efficacy of the devices on the market, with a focus on monitoring and continuous improvement.<\/h5>\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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From start to finish<\/b>, all the phases of the lifecycle of the product.<\/h1>\t\t\t\t<\/div>\n\t\t\t\t
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Eurosets<\/strong>\u2019 QMS embraces all the phase of the lifecycle of the product, starting from the design, development, manufacture, and distribution of medical devices.<\/p>

Our QMS is certified according to ISO13485 standard and Medica Device single audit Program (MDSAP) for Canada, USA, Brazil, Australia and Japan, and complies with regulation EU 2017\/745 (MDR) requirements.<\/p>

The synergy between Quality Assurance, Regulatory Affairs and Quality Control department ensures the ability of Eurosets to provide safe and effective products which meet government regulations, to guarantee the availability of its products all over the world, currently in over 80 countries and satisfy all requirements of our customers.<\/p>

Eurosets<\/strong>\u2019 Quality Assurance team\u00a0offers the customer post-marketing assistance, defining actions to improve products and ensure performance and safety characteristics of the product.<\/p>

Eurosets<\/strong>\u2019 Regulatory Affairs team assure compliance with applicable medical device regulations, guidance, and standards for jurisdictions where devices are marketed and creates and maintains documentation required to demonstrate compliance to Medical Device regulations and standards.<\/p>

Eurosets<\/strong>\u2019 Quality Control Team performs inspections starting from the raw materials down to the finished products to guarantee compliance of the product\u2019s quality to the European and International Regulatory requirements.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t

\n\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\tDownload the certifications<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Certified quality<\/b><\/h1>\t\t\t\t<\/div>\n\t\t\t\t
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Eurosets\u2019 certification scope is design and development, production and distribution of Medical Devices and components for transfusion, auto-transfusion, filtration, drainage, washing, vacuum generators, circuits and components for Extracorporeal and infusional circulation, blood oxygenating devices for Extracorporeal circulation, wound therapy and blood monitoring systems for the main parameters of extracorporeal circulation, equipment and disposable circuit for partial CO2 removal and optional hemofiltration in extracorporeal circulation, centrifugal blood pump equipment and disposable blood centrifugal pumps, heather-cooler units for extracorporeal circulation.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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Documentation Download:<\/h1>\t\t\t\t<\/div>\n\t\t\t\t
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