Viromed Medical AG Achieves ISO 13485 Certification, Clears Path for ViroCAP® Market Launch
Viromed Medical AG's ISO 13485 certification enables independent market entry for its ViroCAP® cold plasma medical devices, positioning the company for accelerated growth in dermatology and veterinary markets starting October 2025.
Viromed Medical AG has received ISO 13485 certification, officially establishing the company as a medical device manufacturer and enabling the independent approval and marketing of its ViroCAP® mobile medical devices for skin disease treatment. The certification represents a critical milestone that transforms Viromed from a developer into an approved manufacturer, providing significant competitive advantages and new revenue potential according to CEO Uwe Perbandt.
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 an international standard quality management system. This achievement lays the foundation for accelerated product launches and sustainable revenue growth, with sales and deliveries of the first ViroCAP® devices scheduled to begin in October 2025.
Viromed's ViroCAP® product range addresses multiple markets, including ViroCAP® derma and ViroCAP® med for dermatology and wound treatment applications, along with ViroCAP® vet for veterinary use. Both the dermatology and veterinary versions can be launched immediately following certification. The ViroCAP® device weighs just 160 grams, making it the world's lightest mobile device for cold plasma applications, and features contact-free treatment technology that eliminates direct skin or wound contact.
The certification provides Viromed with significant flexibility and speed in market entry for class-I-risk products, allowing the company to tap into attractive growth areas in dermatology and clinical environments. This regulatory achievement not only facilitates the company's market expansion but also supports its broader mission of advancing cold plasma technology applications in medicine. Additional information about the company is available at https://www.viromed-medical-ag.de.