Roosin Medical Achieves EU MDR Certification: Setting A New Benchmark in Advanced Wound Care

Roosin Medical has officially attained the EU Medical Device Regulation (EU MDR 2017/745) certification, audited and issued by TÜV Rheinland. This regulatory milestone validates the safety, clinical efficacy, and manufacturing standards of Roosin Medical's advanced wound dressing portfolio, further reinforcing its compliance in the European and international medical markets.

• Strict Regulatory Compliance: The EU MDR replaces the former MDD with elevated standards for clinical evaluation, risk management, and post-market surveillance (PMS). Achieving this certification demonstrates full alignment with the world's most stringent medical regulations.
• TÜV Rheinland Audited: Evaluated by one of the globe's foremost notified bodies, ensuring rigorous oversight of quality management systems and technical documentation.
• Export-Ready Wound Solutions: Expedites market access across the European Union and recognized regulatory bodies worldwide, ensuring uninterrupted supply-chain reliability for B2B distributors and healthcare institutions.
• Focus on Advanced Wound Care: Covers core wound management products, supporting enhanced patient outcomes, infection control, and exudate management.

Transitioning to EU MDR is a strategic requirement for sustainable global distribution. Roosin Medical integrates ISO 13485-certified manufacturing with full regulatory transparency, offering international procurement teams:

1. Fully Traceable Production: End-to-end quality assurance from raw material sourcing to packaging.
2. Regulatory & Technical Support: Complete technical files, certificates of analysis (COA), and documentation for rapid local registration.
3. Flexible OEM/ODM Capabilities: Scalable supply options for hospital tenders, private-label distributors, and medical brands.

Roosin Medical is a specialized manufacturer and supplier of advanced wound care dressings and medical consumables. Partnering with global distributors, healthcare providers, and OEM clients, Roosin Medical delivers certified, clinically evaluated solutions designed to elevate patient recovery worldwide.