Medical device assembly & production
The production of medical devices often requires automated assembly lines capable of manufacturing intricate devices.
Devices such as hypodermic needles, inhalers, and contact lenses must be deemed safe enough to come into contact with the human body. With stringent standards in place and production processes often taking place within cleanrooms, quality control of these products is paramount.
As a result, medical device manufacturers are constantly challenged to improve assembly and testing processes without compromising the quality or safety of the product.
Specialist support from Sewtec Automation
Sewtec Automation invents, designs, manufactures, installs, and supports automated equipment to enhance medical device production. Our systems can transform your Overall Equipment Effectiveness (OEE), which improves both production rates and quality.
Our extensive experience with medical device assembly systems enables us to develop automation systems to meet any requirement. Whether automating assembly, vision inspection, or validation processes, our turnkey solutions can bring long-term benefits to your business. We have the capabilities to manage a full project in line with Construction Design & Management (CDM) regulations.
Thanks to our in-house precision engineering capabilities, you can benefit from that all-important peace of mind. Our team of experts can help transform your manufacturing processes and continuously optimise your production lines over their full lifespan.
We can help your business adhere to the following standards:
- TÜV SÜD validation
- The Current Good Manufacturing Practice (CGMP) regulations enforced by the Food and Drug Administration (FDA)
The in-depth knowledge we have of serialisation also allows us to aid the traceability of your products through the supply chain. This enables you to comply with the following:
- The Food and Drug Administration’s (FDA) mandatory Unique Device Identifiers (UDI) regulations
- The new EU Medical Device Regulations (MDR) 2017/745
Medical device automation capabilities
Our medical device automation systems are designed to optimise a range of critical manufacturing processes.
Our turnkey approach to precision engineering allows us to automate even the most complex of assembly processes. This ensures medical devices such as needleless injectors, specialist syringes, and medical tubing can be manufactured at optimal efficiency.
Our packaging lines take an assembled medical device and wrap or seal it into its required outer packaging, including sterile barrier systems.
Our medical device handling capabilities ensure components and assembled products can transition smoothly between different stages of the assembly, quality control, or packaging process.
The correct labelling of medical devices is essential for enabling supply chain traceability. Our high-speed labelling lines ensure your products are carefully and correctly labelled prior to despatch.
Our track and trace systems ensure your medical device can be traced back to a specific stage of the supply chain. The fast and accurate application of UDIs aids the product return and recall process.
Our product testing and inspection lines are designed to ensure the utmost quality of every medical device that leaves your factory. This provides quality and compliance with the industry’s stringent global standards.
Our in-house expertise ensures we can advise on how suitable the design of your medical device is for process automation. From the size and shape of components to packaging, we can work with you to develop a product which is Design For Automation (DFA) ready.
Medical device assembly and production case studies
Our in-house capabilities enable us to work in partnership with you on your next medical device automation project.
Find out more about our experience in developing a range of systems by reading this case study on an automated medical device assembly machine.