Quality Management
Regen Lab Quality System Management ensures the consistency of our products quality at every stage, from design to production and distribution
Quality Product & Management | Leading the Future of Regenerative Medicine
At Regen Lab, we are dedicated to advancing regenerative medicine through the development, manufacture, and distribution of medical devices.
Our commitment to quality and safety is at the core of our operations, ensuring the highest standards in patient care and user safety.
Our Commitment to Quality
Compliance and Standards: Our Quality System Management follows the European regulation requirement according to (EU) MDR 2017/745 and European Directive 93/42EEC for product still on the transition, the 21 CFR 820 and other applicable regulatory requirements. We operate within the ISO 13485 framework, ensuring our management systems meet rigorous medical device manufacturing requirements.
Innovative Production Facilities: We have established state-of-the-art production aera equipped with high technologies. This ensures the manufacture of reliable, high-quality devices while maintaining a focus on employee well-being.
Quality System Management
Our Quality System Management ensures the consistency of our products quality at every stage, from design to production and distribution in accordance to standard ISO 13485 by minimised risks, enhances patient safety and performance
PatentsCERTIFICATIONS
The Future of Regenerative Medicine
Advanced Production Facility
Our production facility demonstrated our commitment to quality and innovation. Our infrastructure supports efficient manufacturing processes. We prioritize an environmental control, maintaining stringent atmospheric controls in our production aeras to meet the highest standards of medical device manufacturing.
Quality System Management
At Regen Lab, consistency in product quality is paramount. Our Quality System Management ensures every device meets rigorous standards. We adhere to the ISO 13485 standard, integrating essential requirements into our management systems to ensure excellence in medical device manufacturing.
Regulatory Compliance
Regen Lab follows a rigorous approach to regulatory compliance and Quality System Management. We operate within the framework of ISO 13485 standard, ensuring that our management systems meet the highest standards required for medical device manufacturers. Additionally, our quality system complies with the European Regulation 2017/745 on medical devices, underscoring our dedication to quality and safety.
