Viromed Medical AG Achieves ISO 13485 Certification, Enabling October 2025 Launch of ViroCAP® Medical Devices

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. This certification represents a critical milestone that transforms Viromed from a developer into an approved manufacturer, providing significant competitive advantages and new revenue potential while accelerating market entry for its innovative cold plasma technology products.

The ISO 13485 certification serves as a key 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 sustainable revenue growth and market expansion, with sales and deliveries of the first ViroCAP® devices scheduled to begin in October 2025. The certification enables Viromed to independently certify class-I-risk products, providing the company with substantial flexibility and speed in bringing its medical devices to market.

Viromed's ViroCAP® product range addresses multiple market segments, including ViroCAP® derma and ViroCAP® med for dermatology and wound treatment applications, along with ViroCAP® vet for veterinary use. Both the dermatology and veterinary devices can be launched immediately following certification receipt. Weighing just 160 grams, the ViroCAP® represents the world's lightest mobile device for cold plasma applications, featuring contact-free treatment technology that eliminates the need for direct skin or wound contact.

The company's achievement positions it to tap into attractive growth areas within dermatology and clinical environments, leveraging its innovative cold plasma technology to advance medical treatment options. This certification milestone not only facilitates immediate product launches but also establishes a framework for future medical device development and market expansion, supporting Viromed's broader objectives in the medical technology sector. Additional information about the company and its technology can be found at https://www.viromed-medical-ag.de.