Medizintechnik Promedt GmbH is a forward-thinking, medium-sized company based in Tornesch, near Hamburg.
It was the first company in Germany to be certified according to DIN ISO 9001 / EN 29001 for medical technology and has since achieved success in the development, approval, and production of medical technology products.
Our focus is on the high-quality implementation of individual customer requirements, in compliance with DIN EN ISO 13485.
Our employees’ understanding and awareness of quality are essential for meeting the highest standards. That’s why we invest in a broad range of employee expertise and the latest technologies to ensure the reproducible quality of our medical devices.
Medizintechnik Promedt is your expert partner across the entire value chain—from consulting and development to the single-unit and series production of certified medical devices—all from a single source.
Over the years, Medizintechnik Promedt has obtained several patents in the field of medical technology. Recent developments, especially in the area of water treatment, are also protected by patents.
Successful internal company succession
Successful certification according to MDR 2017/645
Development of a pooling bag system for the intermediate filling of parenteral nutrient solution (pharmaceutical means of production)
Development of a syringe-bag system to support parenteral nutrition solution filling (pharmaceutical means of production)
Development of a sterile filter set to support the filling process of parenteral nutrition bags (pharmaceutical production equipment)
Transition of QM Certification to ISO 13485:2016 and MDSAP for Canada, Brazil, and Australia.
Development of a tubing system with an innovative valve unit for the industrial filling of parenteral nutrition bags under GMP conditions.
Completion of a new warehouse and office extension. Certification for the distribution of medical devices in Canada (SOR/98-282).
Development of an apheresis tubing system aimed at removing free tumor cells from patient blood using an adsorber.
Development of an infusion line for compensating citrate anticoagulation in continuous renal replacement therapy.
Double-Blind Study: Development of an application system for a global clinical study of a well-known pharmaceutical company; application systems became a new business sector.
Certification according to DIN EN ISO 13485.
Development and Manufacture of an autologous blood treatment set.
Partner for the development and production of a liver-supportive therapy system.
Start of OEM manufacturing as a partner for renowned large companies.
Certification according to EN 46001.Establishment of the sister company MT Promedt Consulting, which operates internationally in all areas of Regulatory Affairs, such as preparation for CE certification, global product approvals (FDA, EU), creation of technical dossiers, clinical trials, etc.
Development and production of fill sets for implanted medication pumps.
Certification according to DIN ISO 9001 / EN 29001 as the first medical technology company in Germany.Development of steam-sterilizable blood tubing systems in a specially developed autoclave.
Development of the sterilization of PVC tubing systems using ionizing radiation.
Founding of Medizintechnik Promedt GmbH by Klaus G. Büttner.