Quality
Quality & Regulatory Compliance
Quality is the foundation of everything we do at MEM. Our Quality Management System is certified to ISO 13485:2016, supporting the design, manufacture, and distribution of orthodontic medical devices. We are committed to delivering safe, reliable, and high-quality products that consistently meet customer and regulatory expectations worldwide.
Quality Control & Assurance
Every stage of our manufacturing process is carefully monitored—from incoming material inspection and production processes to final product verification. Supported by documented procedures, calibrated equipment, qualified personnel, and a culture of continuous improvement, MEM ensures consistent product quality, reliability, and customer satisfaction.
Certifications & Regulatory Compliance
MEM is committed to meeting internationally recognized quality standards and medical device regulations. Our products are manufactured under a certified Quality Management System and comply with applicable regulatory requirements in the markets where they are supplied.
Our quality and regulatory compliance include:
Certified Quality Management System for Medical Devices
Compliance with the European Medical Device Regulation (EU MDR 2017/745)
Compliance with applicable U.S. FDA medical device regulatory requirements
Products are registered and/or comply with applicable medical device regulations and registration requirements in countries and regions where they are marketed.