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Clean room production medical technology

Product development

Product development at Murrplastik Medizintechnik takes place under strict clean room conditions (ISO class 7) in the subsequent manufacturing process to ensure that the medical technology products manufactured meet the highest quality and hygiene standards. This ensures the safety and effectiveness of the injection molded components and assemblies produced.

Concept and design

Product development begins with the conception and design of new medical products. This includes the identification of requirements and specifications in close cooperation with medical experts and customers.

Material selection

Materials are selected that meet the high standards of medical technology. These materials must be biocompatible and sterilizable to ensure patient safety and product quality.

Risk management

The identification and assessment of risks is an important aspect for the validation of medical devices. This is a practiced process at Murrplastik Medizintechnik and helps to minimize potential hazards and implement risk mitigation measures.
Prototype development: Prototypes are needed to extensively test the functions and requirements in the production of the subsequent series articles under clean room conditions.


At the beginning, a comprehensive validation plan is drawn up that defines the specific objectives, methods, responsibilities and phases (DQ; IQ; OQ; PQ) for the validation. This plan is drawn up in accordance with the applicable regulations and standards (MDR; FDA: etc.).

Documentation and certification

All steps in the development and production process are carefully documented to ensure product traceability. In addition, the products are certified in accordance with the applicable regulations and standards (MDR; FDA; etc.).

3D printing of prototypes

3D printing of prototypes is a common practice in the medical technology and manufacturing industry. Murrplastik Medizintechnik uses 3D printing technologies to produce prototypes of future injection-molded components and assemblies. These prototypes are used for design testing, functional testing and product development purposes.

3d-Druck von Prototypen Medizintechnik

Injection molding production in ISO class 7 clean room (EN ISO 14644)


The actual production of medical technology products takes place in ISO class 7 cleanrooms to prevent contamination. Employees wear special protective clothing and work under controlled conditions to ensure that the products are free from contamination.


The assembly of injection-molded components into complete assemblies is carried out in compliance with the specific clean room conditions and according to precisely defined manufacturing guidelines. Murrplastik Medizintechnik has established assembly methods such as bonding, ultrasonic welding, laser marking and a variety of devices and testing technology.

Quality control

Strict quality control procedures are carried out throughout the production process to ensure that the products manufactured meet the specified standards and customer requirements. This includes, for example, tests for material integrity, dimensional accuracy and sterility.

Packaging and sterilization

The end products are packaged in ISO Class 7 cleanrooms and then sterilized by a long-standing external service provider to ensure that they are free of germs and contamination when they reach the customer.

Reinraumfertigung Medizintechnik