In medical device manufacturing, reliable supplier cooperation depends on traceable processes, disciplined quality management and clearly defined production procedures. Since 2004, we have been working with components and assembled units for medical devices. Our manufacturing experience, cleanroom capabilities and related inspection procedures form part of an established production system available to our partners.
We manufacture plastic and metal components for medical devices according to individual customer requirements. For plastic components, our injection molding and toolmaking capabilities provide additional support, particularly when production launch, modifications or transition to series production are also part of the project.
Assembly processes can be carried out in an ISO Class 8 cleanroom environment. This is particularly important for medical technology and healthcare industry projects where a controlled manufacturing environment, clean working processes and documented operations form part of supplier compliance requirements.
Inspections related to manufacturing and assembly help ensure that products are produced in accordance with specified technical and quality requirements. Measurements, tests and feedback support production stability and make future cooperation more predictable and easier to plan.
Packaging operations can also be included as part of the medical device manufacturing process. Our available equipment and workflows allow components or assembled units to be prepared and delivered according to the specific requirements of each project.
Quality management is a fundamental technical and business requirement in medical device manufacturing. Our company operates in accordance with ISO 13485 requirements and undergoes annual audits. We also provide an ISO Class 8 cleanroom environment for assembly, testing and packaging operations. In 2025, our company successfully underwent an audit by the U.S. Food and Drug Administration (FDA), further reinforcing our commitment to high quality standards.
Documented processes are also an important factor in supplier selection. Customers typically assess whether a manufacturing partner can support a project with traceable processes, consistent quality, appropriate change management and fast professional feedback. In this environment, our company is prepared to cooperate both as a manufacturing partner and as a supplier to the medical technology industry.
Our medical device manufacturing activities are supported by our own cleanroom and assembly facilities. Available equipment includes ultrasonic cleaning systems, ovens, pad printing equipment, microscopes, soldering equipment, EFD dispensing systems and heat-sealing equipment for packaging applications.
This equipment enables us to perform a variety of individual operations within the medical technology manufacturing process. Our aim is always to establish a controlled and traceable production process tailored to the product and aligned with the customer’s technical and quality requirements.
One of the key advantages of L.Z. Form Ltd. is that medical device manufacturing can be combined with our plastic injection molding and toolmaking capabilities. This is particularly valuable when a project requires the production of plastic components for medical technology, the assembly of injection-molded parts or the rapid implementation of production-related modifications.
The integration of manufacturing processes in-house reduces coordination rounds, accelerates technical feedback and makes responsibilities more transparent. Tool modifications, injection molding trials, component manufacturing and assembly can all be managed within one integrated system, providing practical advantages both during production launch and throughout series production.
What exactly do we provide in the field of medical device manufacturing?
We manufacture plastic and metal components for medical devices and provide injection molding, cleanroom assembly, testing and packaging services.
Which certification is relevant to our medical device manufacturing activities?
Our medical device manufacturing operations comply with ISO 13485 requirements and are audited annually. We also hold ISO 9001 quality management certification.
Do we manufacture plastic components for medical technology applications?
Yes. We manufacture plastic components for medical technology applications. Our injection molding and toolmaking capabilities can support development, production launch and series production projects.
What types of partners can benefit from L.Z. Form Ltd.’s medical device manufacturing services?
We can be a suitable manufacturing partner for companies looking for a supplier of medical devices, medical technology components or assembled units. Our services may be particularly relevant to medical technology manufacturers, product development companies, contract manufacturers, local or European participants in international supply chains, and industrial partners looking for controlled manufacturing and assembly capabilities.
What information is required for a quotation?
For project assessment, it is useful to provide any available drawings, 3D models or sample parts, together with planned quantities, material requirements, cleanroom or packaging requirements, and applicable quality and documentation specifications. Based on this information, we can assess the required manufacturing steps, capacity and preparation more efficiently.
To which countries has L.Z. Form Ltd. already supplied products related to medical device manufacturing?
We have gained experience across several international markets. Manufacturers in the United States, Costa Rica, Thailand, China, Italy and Ireland have already trusted us as a manufacturing partner.
How does the cooperation begin?
The first step is to understand the product and its manufacturing requirements. During the technical consultation, we review the function of the component or assembled unit, the required production stages, quality and documentation requirements, as well as planned quantities and scheduling.
Based on this information, we determine how we can support the project – through component manufacturing, injection molding for medical technology applications, cleanroom assembly, testing, packaging or a combination of these services. Our aim is to make both the quotation process and project launch transparent, technically precise and decision-oriented from the outset.
