Medical Corp LLC is certified to SR EN ISO 9001:2015 and SR EN ISO 13485:2016.
Furthermore, Medical Corp holds Operating Permit No. 8393/12.09.2022 issued by the National Agency for Medicines and Medical Devices of Romania for the marketing, repair, verification, and commissioning of medical devices.
The ISO 13485 standard is a certification standard for quality management developed for the medical devices sector. The full title, "Medical devices – Quality management systems – Requirements for regulatory purposes," indicates the demonstration of compliance with regulations, internationally recognized by those operating in the industry.
The term "medical device" corresponds to thousands of different products, from the simplest to the most complex. The regulatory framework of the medical devices sector has been tightening in recent times, and with the arrival of European Regulations 2017/745 and 2017/746, manufacturers and distributors must demonstrate control over risk and traceability throughout the entire lifecycle of the medical device.