Validated ethylene oxide sterilization for medical plastic devices. Includes process validation, documentation, and full regulatory compliance for MDR and FDA requirements.
Manufactured by
Parchim, Germany
RoweMed AG - Medical 4 Life is an innovative MedTech company. Our focus is on the development and production of medical plastic products, especially complex customized systems for the handling of sensitive drugs. We realize turnkey projects for our customers from the first sketch to CAD design and rapid prototyping to the approved serial product. For our projects we offer full documentation according to the Medical Device Directive 93/42/EEC. In our certified clean rooms (ISO 7) we offer injection molding, assembly and packaging from one source. Thus, we realize single-item production, small series and automated large series with high efficiency.
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