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 unlock market access for novel medical technologies, potentially improving treatment options in areas like dermatology where the ViroCAP® systems offer non-contact solutions. The certification also highlights the importance of quality management systems in ensuring patient safety and product reliability, which is crucial as medical devices become more advanced and integrated into clinical practice.
The implications of this announcement extend beyond Viromed's corporate growth, potentially influencing the broader adoption of cold plasma technology in healthcare. By meeting ISO 13485 standards, Viromed sets a benchmark for other medical device startups seeking to navigate complex regulatory landscapes. The independent market launch capability reduces reliance on third-party manufacturers, giving Viromed greater control over production timelines and quality assurance. This is particularly important for specialized devices like the ViroCAP® family, where precision and consistency are critical for therapeutic effectiveness. The October 2025 launch timeline provides a clear roadmap for healthcare providers and investors, signaling Viromed's commitment to bringing innovative solutions to market in a structured and compliant manner.
Furthermore, the certification enables Viromed to expand into international markets more efficiently, as ISO 13485 is recognized globally as a standard for medical device quality management. This could accelerate the availability of cold plasma technology in regions with high demand for advanced wound care and dermatological treatments. The lightweight design of the ViroCAP® device, combined with its contact-free operation, addresses practical challenges in clinical settings where portability and infection control are priorities. As healthcare systems increasingly seek cost-effective and minimally invasive treatment options, Viromed's certification positions the company to contribute to these trends while maintaining rigorous quality standards. The announcement underscores how regulatory achievements can serve as catalysts for medical innovation, bridging the gap between technological development and real-world clinical application.
