Feellife acquires an exciting development in our ongoing journey toward excellence in medical device manufacturing. A total of 78 more products in our portfolio have recently received certification under the European Union Medical Device Regulation (EU MDR), one of the world’s most demanding regulatory systems. This accomplishment underscores our unwavering dedication to delivering high-quality, compliant, and trustworthy medical solutions to healthcare professionals and patients around the world.
Introduced to enhance patient safety and improve the performance of medical devices across Europe, the EU MDR (Regulation (EU) 2017/745) represents a significant shift from the previous MDD (Medical Device Directive). It places a strong emphasis on clinical evaluation, traceability, post-market monitoring, and a comprehensive approach to risk management.
To meet the MDR’s strict requirements, each of the 78 newly certified Feellife products underwent extensive evaluation, including:
In-depth Clinical Validation: Demonstrating that each device performs safely and effectively in real-world settings.
Robust Risk Analysis: Identifying and mitigating all potential hazards throughout the product lifecycle in line with international standards.
Certified Quality Management Systems: Ensuring that Feellife’s manufacturing and operational processes adhere to ISO 13485 and are consistently reviewed by notified bodies.
Comprehensive Technical Documentation: Compiling evidence that the products conform to all applicable safety and performance requirements.
Achieving this level of compliance is not only a technical success but also a strategic one. It enables Feellife to enhance its presence in the European market and strengthens our partnerships with distributors, clinics, hospitals, and patients who demand the highest standards of quality and safety.
It reinforces our promise to provide safe, effective, and innovative products that meet the evolving needs of global healthcare systems.
As the global healthcare landscape continues to evolve, regulatory expectations are becoming more rigorous. Feellife not only embraces these higher standards—we are actively advancing them through continual investment in compliance, innovation, and user-centered design.