Viromed Medical AG has received ISO 13485 certification, officially establishing the company as a medical device manufacturer and enabling the independent market launch of its ViroCAP® product family beginning October 2025. This certification represents a critical milestone that transforms Viromed from a developer into an approved manufacturer, providing significant competitive advantages and new revenue potential.
The ISO 13485 certification is a fundamental requirement for medical device approval in Europe under the Medical Device Regulation (MDR), certifying that Viromed has successfully implemented a quality management system meeting international standards. This achievement lays the foundation for accelerated product market entry and sustainable revenue growth, according to company leadership.
CEO Uwe Perbandt emphasized the strategic importance of this development, stating that the certification enables Viromed to bring products to market independently and quickly. The company expects the introduction of ViroCAP® systems to provide substantial growth momentum and market position expansion.
The ViroCAP® product range addresses multiple medical markets, with ViroCAP® derma and ViroCAP® med designed for dermatology and wound treatment applications, while ViroCAP® vet targets veterinary use. Both ViroCAP® derma and ViroCAP® vet can be launched immediately following certification receipt. The device weighs just 160 grams, making it the world's lightest mobile cold plasma application device, and features contact-free treatment technology that eliminates direct skin or wound contact.
With the ability to independently certify class-I-risk products, Viromed gains significant flexibility and speed in market entry, positioning the company to capitalize on attractive growth opportunities in dermatology and clinical environments. The certification enables Viromed to approve and market ViroCAP® as a mobile medical device for skin disease treatment, with sales and deliveries of the first devices commencing in October 2025.
