Viromed Medical AG Achieves ISO 13485 Certification, Clears Path for ViroCAP® Market Launch in October 2025

Viromed Medical AG has obtained 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 for the medical technology company, allowing it to independently approve and market its mobile medical devices for skin disease treatment without relying on external manufacturing partners.

The ISO 13485 certification is a mandatory requirement for medical device approval in Europe under the Medical Device Regulation (MDR), confirming that Viromed has successfully implemented an international standard quality management system. CEO Uwe Perbandt emphasized the strategic significance, stating that this transition from developer to approved manufacturer provides both new revenue potential and a clear competitive advantage in the medical technology sector.

Viromed's 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 medicine. The 160-gram ViroCAP® device represents the world's lightest mobile cold plasma application system, featuring contact-free treatment technology that eliminates direct skin or wound contact during procedures.

The certification enables Viromed to independently certify class-I-risk products, providing significant flexibility and speed in market entry strategies. This capability allows the company to immediately launch ViroCAP® derma and ViroCAP® vet products following certificate receipt, positioning Viromed to capture growth opportunities in dermatology and clinical environments. The company anticipates that the ViroCAP® system introduction will drive substantial growth and market position expansion, leveraging its established customer base in the DACH region and beyond. Additional information about the company's developments can be found at https://www.viromed-medical-ag.de.