Viromed Medical AG Achieves ISO 13485 Certification, Clears Path for ViroCAP® Market Launch in 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 device for skin disease treatment. This certification is a key requirement for medical device approval in Europe under the Medical Device Regulation (MDR), confirming that Viromed has successfully implemented a quality management system meeting international standards. The achievement paves the way for sales and deliveries of the first ViroCAP® devices to begin in October 2025, marking a critical milestone for the company's market entry and growth strategy.

CEO Uwe Perbandt emphasized that the certification transforms Viromed from a developer into an approved manufacturer, providing a competitive advantage by allowing faster and independent product launches. This shift is expected to unlock new revenue potential and strengthen the company's market position, with the ViroCAP® systems anticipated to drive significant growth. The certification also grants Viromed the ability to independently certify class-I-risk products, enhancing flexibility and speed in market entry, which is crucial for tapping into high-growth areas like dermatology and clinical environments.

The ViroCAP® product range targets multiple markets, including ViroCAP® derma and ViroCAP® med for dermatology and wound treatment, and ViroCAP® vet for veterinary use. Both ViroCAP® derma and ViroCAP® vet can be launched immediately following certification. Weighing just 160 grams, the ViroCAP® is the world's lightest mobile device for cold plasma applications, featuring contact-free treatment technology that eliminates direct skin or wound contact, improving safety and usability. This innovation addresses diverse application fields, potentially revolutionizing treatment approaches in medical and veterinary practices.

The implications of this announcement extend beyond Viromed's corporate growth, potentially impacting healthcare providers and patients by offering advanced, portable treatment options for skin diseases and wounds. For the medical technology industry, it underscores the importance of regulatory compliance and quality management in accelerating product launches. The successful certification and upcoming market entry of ViroCAP® devices may inspire similar innovations, fostering competition and advancement in cold plasma technology applications. Overall, this development highlights Viromed's strategic progress and its potential to contribute to medical treatment efficiencies and outcomes globally. Further details can be found on the company's website at https://www.viromed-medical-ag.de.