SEM Biotech is a biomedical manufacturing company built on an industrial production culture and decades of engineering expertise.
Designed to transfer an industrial heritage dating back to 1975 into the medical field, SEM Biotech operates in the area of vacuum blood collection systems.
Founded as an R&D project in 2022, SEM Biotech commenced serial production activities following the completion of infrastructure development and validation processes.
Our main product group, developed for the medical device sector, consists of Vacuum Blood Collection Tubes manufactured in accordance with international standards.
Our production processes are carried out under ISO Class 8 clean room conditions, based on traceability, repeatability, and consistent quality principles.
Our aim is to provide long-term and sustainable solutions for the healthcare sector through products that support accuracy and reliability in laboratory diagnostic processes and fully comply with regulatory requirements.
The industrial production culture and engineering background on which SEM Biotech is built are based on long-standing manufacturing experience dating back to 1975.
SEM Biotech was structured as an R&D project in 2022 with a focus on vacuum blood collection systems.
Production infrastructure was established, process validations were completed, and serial production was initiated under ISO Class 8 clean room conditions.
Today, SEM Biotech continues its operations with a focus on regulatory compliance, traceability, and sustainable manufacturing, with vacuum blood collection tubes as its main product group.
To combine our expertise in plastic technology with biotechnology and become a global reference point in laboratory safety. Through our production quality that sets standards, we aim to shorten the path to accurate diagnosis and effective treatment worldwide.
To transfer our half-century industrial manufacturing experience and "zero-defect" culture into medical technology, providing healthcare professionals with the most reliable analytical environment. With the awareness that behind every tube we produce there is a person awaiting accurate results, we strive to be the invisible force ensuring flawless diagnostic processes.
To comply with the requirements of TS EN ISO 13485 Medical Devices Quality Management System standards, ensure their effectiveness, and pursue continuous improvement,
To fully comply with the requirements of Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR) and to meet all applicable legal and regulatory obligations,
To consider customer expectations, requests, and feedback, measure customer satisfaction, and continuously improve our processes and services,
To ensure patient safety through robust quality assurance and risk management practices,
To utilize modern technologies focused on enhancing communication, organization, and coordination across management, production, sales, after-sales, and all internal service processes, and to continuously train our personnel accordingly,
To regularly monitor quality processes, analyze outcomes, implement corrective and preventive actions, and support continuous improvement initiatives,
To ensure that quality awareness is embraced by all employees and, through team participation, to maintain and continually improve the effectiveness, suitability, and sustainability of the quality management system.
