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VT ES Kft. is the second within the VIDEOTON group of companies – after VIDEOTON Elektro-PLAST Kft. – to obtain the ISO 13485 standard for quality management of medical devices.
Following the qualification of the Kaposvár-located VIDEOTON Elektro-PLAST Kft. in 2016, the Székesfehérvár-based VT ES Kft. – dealing with the assembly of final products, low to medium volume sheet metal part manufacturing and powder coating, as well as the development and distribution of Automated Identification technology systems – received the ISO 13485 qualification at the beginning of 2021.
During the certification audit at the Székesfehérvár site of VT ES Kft., the company succeeded to meet the quality management standards through the production processes of two different product types, so the certification is valid for the assembly of three products (two types of air curtain cabinets and an exhaust fan). Therefore, the certification applies to mechanical / electromechanical contract manufacturing of sub-assemblies of active, non-implantable medical devises.
The aim of VT ES Kft. by obtaining this certification is to establish cooperation with as many new partners as possible also in this market segment where our Kaposvár-based member company, VIDEOTON Elektro-PLAST has already gained experience. The company, which is mainly engaged in final assembly and plastic injection moulding, will launch another project in 2021 in the field of manufacturing plastic parts for the control device of surgical robots.