Eurosets’ QMS embraces all the phase of the lifecycle of the product, starting from the design, development, manufacture, and distribution of medical devices.

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.

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.

Eurosets’ Quality Assurance team offers the customer post-marketing assistance, defining actions to improve products and ensure performance and safety characteristics of the product.

Eurosets’ 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.

Eurosets’ Quality Control Team performs inspections starting from the raw materials down to the finished products to guarantee compliance of the product’s quality to the European and International Regulatory requirements.