Viromed Medical AG has received ISO 13485 certification, officially establishing the company as a medical device manufacturer and enabling independent market launch of its ViroCAP® product family beginning October 2025. This certification represents a critical milestone that transforms Viromed from developer to approved manufacturer under European Medical Device Regulation requirements. The ISO 13485 certification validates that Viromed has successfully implemented a quality management system meeting international standards, which is mandatory for medical device approval in Europe according to the Medical Device Regulation. This achievement provides the company with significant flexibility and speed in market entry for class-I-risk products, creating a clear competitive advantage in the medical technology sector.
CEO Uwe Perbandt emphasized the strategic importance of this development, stating that the certification opens new revenue potential and enables independent product marketing. The company anticipates that the ViroCAP® systems will drive substantial growth and market position expansion, particularly in dermatology and clinical environments where cold plasma technology shows promising applications. The ViroCAP® product range addresses multiple market segments, with ViroCAP® derma and ViroCAP® med designed for dermatology and wound treatment applications, while ViroCAP® vet targets veterinary use. Weighing just 160 grams, the ViroCAP® device is recognized as the world's lightest mobile cold plasma application device, featuring contact-free treatment technology that eliminates direct skin or wound contact during procedures.
With immediate market launch capability for ViroCAP® derma and ViroCAP® vet following certification, Viromed is positioned to capitalize on growing demand for innovative medical technologies. The company's transition to full manufacturing capability represents a significant step in advancing cold plasma technology applications in medical treatment, with the October 2025 product launch expected to establish Viromed as a key player in specialized medical device markets. This development matters because it demonstrates how regulatory compliance can enable medical technology companies to bring innovative treatments to market independently, potentially improving patient care through advanced technologies like cold plasma applications in dermatology and wound treatment.
