Product category: Full service manufacturing, electronics
Production and assembly of Medical Devices
High end manufacturer of medical devices. From prototyping , production engineering and assembly of mechatronic and electronic devices. Contract manufacturing from proto to serial production. Scalable manufacturing Unitron produces more than 40 different devices each year in series ranging from one piece to in the ten thousands. Unitron works with flexible workstations in close cooperation with its clients, resulting in high flexibility, high quality, low stock levels and lower production costs. Quality Unitron is ISO 9001-2008, ISO 13485:2012 and Ministerial Ordinance 169 certificated. Our production department works according to the requirements of IPC-A-610D Class 2. The medical device industry is both highly regulated and technically oriented. Laws and guidelines change continuously. At Unitron, both the quality and R&D department have the relevant knowledge to ensure compliance.
Product category: Production engineering, medical systems
In the process to bring a Medical Device from R&D to production, Unitron has developed a solid methode as a Design Transfer process. Unitrons engineering team sets up together with the customer the Process Flow. From Purchasing until After sale service. Based on the step by step aproach of the Process Flow, all possible failures are identified in the manufacturing and assembly process. They are written down together with the impact rate in the Process Risk Analysis called the pFMEA. All documents generated out off this process are part of the Technical File. Validation of the process is done using the IQ, OQ and PQ methode.
Unitron is a high-end manufacturer of medical devices. An innovative partner of leading quality-driven market players, Unitron operates in various medical markets around the world. The production of medical devices is Unitrons core business, from prototyping and production engineering to the production and assembly of mechatronic and electronic parts.
In the medical devices market, technical and technological developments take place in rapid succession. Unitron work together with partners to achieve breakthroughs in the areas of technical solutions, cost efficiency and logistics. Consequently, Unitron delivers the best business results. Accelerating development and cutting costs Unitron plays an active role in the research, cure and care market and has a proven track record in the development and production of medical devices. Knowledge sharing At Unitron we believe that sharing knowledge and experiences drives quality forward. Characteristic of Unitron is a continuous pursuit of optimal production and a no-fail end product. Unitron challenges all stakeholders to be critical and initiate improvement proposals with regard to technology, cost and quality. Reliability Unitron is a stable and financially healthy company that operates within an extensive network, both nationally and internationally. We also maintain close contact with leading research and knowledge institutes. This yields business opportunities for our partners and possibilities to develop partnerships in order to create an environment of knowledge sharing and co-operation.