Medizintechnik
Medizintechnik Promedt GmbH is a German-based company specializing in the development, production, and sterilization of medical single-use products. With over 44 years of experience, they offer innovative solutions, numerous patents, and adhere to high-quality standards such as DIN EN ISO 13485. The company focuses on customized medical device solutions, including systems for autologous blood treatment and pain therapy, and is certified according to international standards. They invest in quality, new technologies, and skilled personnel to ensure continuous development and compliance with regulatory requirements.
Industries
Nr. of Employees
small (1-50)
Medizintechnik
Tornesch, Schleswig-Holstein, Germany, Europe
Products
Single-use tubing systems for extracorporeal and apheresis applications
Tubing sets and system-specific solutions for extracorporeal blood treatments and apheresis procedures (e.g., hemoperfusion, plasma exchange, hemofiltration, immunoadsorption).
Refill sets for implantable medication pumps
Refill sets and refill systems designed for use with implantable medication pumps for pain therapy.
Systems for autologous blood treatment
Complete systems and sets intended for autologous blood treatment procedures.
Pooling bag and syringe-bag systems for parenteral nutrition
Pooling bag system for intermediate filling of parenteral nutrition and syringe-bag system to support parenteral nutrition filling processes (pharmaceutical production aids).
Sterile filter sets for parenteral bag filling
Sterile filter sets developed to support filling operations of parenteral nutrition bags and similar pharmaceutical production tasks.
Single-use tubing systems for extracorporeal and apheresis applications
Tubing sets and system-specific solutions for extracorporeal blood treatments and apheresis procedures (e.g., hemoperfusion, plasma exchange, hemofiltration, immunoadsorption).
Refill sets for implantable medication pumps
Refill sets and refill systems designed for use with implantable medication pumps for pain therapy.
Systems for autologous blood treatment
Complete systems and sets intended for autologous blood treatment procedures.
Pooling bag and syringe-bag systems for parenteral nutrition
Pooling bag system for intermediate filling of parenteral nutrition and syringe-bag system to support parenteral nutrition filling processes (pharmaceutical production aids).
Sterile filter sets for parenteral bag filling
Sterile filter sets developed to support filling operations of parenteral nutrition bags and similar pharmaceutical production tasks.
Services
End-to-end device development
Concept design, prototyping, pilot/zero-series production, technical documentation and regulatory support through to product release.
Cleanroom production and sterile assembly
Assembly and manufacture of sterile single-use medical products in a Class 8 cleanroom with options for laminar flow workstation production.
Sterilization and sterilization validation
Execution and validation of sterilization processes in compliance with relevant European standards, coordinated with experienced sterilization partners.
OEM / contract manufacturing
Contract manufacturing services including prototype fabrication, pilot production and serial production of medical devices to customer specifications and required sterilization methods.
Regulatory documentation and certification support
Preparation of regulatory documentation and support for product certification and market approval processes under ISO 13485, MDSAP and EU MDR frameworks.
Project planning and commercialization
Project planning services to coordinate development, validation and production activities to support product commercialization.
End-to-end device development
Concept design, prototyping, pilot/zero-series production, technical documentation and regulatory support through to product release.
Cleanroom production and sterile assembly
Assembly and manufacture of sterile single-use medical products in a Class 8 cleanroom with options for laminar flow workstation production.
Sterilization and sterilization validation
Execution and validation of sterilization processes in compliance with relevant European standards, coordinated with experienced sterilization partners.
OEM / contract manufacturing
Contract manufacturing services including prototype fabrication, pilot production and serial production of medical devices to customer specifications and required sterilization methods.
Regulatory documentation and certification support
Preparation of regulatory documentation and support for product certification and market approval processes under ISO 13485, MDSAP and EU MDR frameworks.
Project planning and commercialization
Project planning services to coordinate development, validation and production activities to support product commercialization.
Expertise Areas
- Single-use medical device development
- Cleanroom and sterile manufacturing
- Sterilization process development and validation
- Sterile packaging validation
Key Technologies
- Cleanroom manufacturing (Class 8)
- Laminar flow production
- Sterilization process development and validation
- Sterile packaging validation (DIN EN 11607)