We will work together to find the ideal solution

Cleanroom-quality plastic injection moulding for medical industry products

As development partner in the medical industry, we use injection moulding processes to develop customized and certified plastic solutions from the cleanroom. To ensure the highest requirements are met, our specialists are highly trained and experienced in all areas of expertise.

Plastics engineering

From the very earliest opportunity, GEMÜ clarifies its customers' requirements for injection-moulded parts in the medical industry in order to provide optimum support in all aspects of product development. GEMÜ provides all the requisite skills from a single source: From concept design to tool manufacturing, from material advice to regulatory support. Simulations, rapid prototyping and pre-series samples are integral to the research and development process – ensuring a seamless transition into series production.

Range of cleanroom services

GEMÜ utilizes cutting-edge technologies to create much sought-after complete solutions for the medical industry. In addition to our core skills in the field of plastic injection moulding, we integrate laser welding or ultrasound welding, printing technologies and assembly stations for tested and packaged system solutions. We apply the same integrative approach to implement our customers' sterilization processes. We have the expertise for controlling, integrating and performing all the relevant procedures.

Cleanroom capacity

Our environment meets the highest cleanroom standards (ISO 6 to 9). This enables us to process a wide range of part sizes and specific materials. The cleanroom manufacturing certified to ISO 13485 standard is completed using semi-automated or fully-automated injection moulding machines (35–450 t clamping force). Using our plastic injection moulding know-how, we are able to meet every customer requirement when it comes to the cleanroom medical industry – including assembly of entire system solutions.

Tool manufacturing

Our in-house tool manufacturing allows for quick reaction times. We develop, design and construct tools in-house or in collaboration with long-standing partners who have specialist expertise in the medical industry. What's more, we ensure tool maintenance as well as required modifications.

Ready to sterilize (RTS) – ready to use (RTU)

Our modern cleanroom concept with ISO 13485 certification allows us to manufacture:

Ready-to-sterilize (RTS) medical products
Ready-to-use (RTU) medical products

In accordance with customer requirements, we develop a concept that meets all their specifications and expectations.

Logistics

In collaboration with our customers, we develop specifically defined packaging and logistics concepts. Tailored to their requirements, GEMÜ offers customized and flexible logistic solutions.

Regulatory Affairs

Right from the development stage, GEMÜ helps its customers to navigate the national and international regulatory requirements. Our in-house Regulatory Affairs department guarantees that your products always comply with the latest regulatory requirements.

The best projects start with a personal consultation.
We look forward to hearing about your idea.