We continue to maintain our ISO 13485 certification, a testament to our commitment to the highest standards of quality management in the medical device industry since May 2022.
ISO 13485 is an internationally recognized standard designed specifically for the medical device industry. It ensures consistent design, development, production, and delivery of medical devices that meet stringent regulatory requirements. This certification underscores our dedication to safety and quality, essential in every step of a product’s life cycle, including service and delivery.
At Memphasys, we understand that safety and quality are non-negotiable. The ISO 13485 certification sets out the requirements for a quality management system that aligns with the rigorous standards of the medical device industry. This achievement reflects our continuous effort to demonstrate best practices in all our processes.
Our commitment to quality is exemplified in the design, development, and manufacture of our active sterile sperm separators, specifically the Felix™ System, for use in assisted reproductive procedures.
Stay tuned for more updates as we continue to lead in reproductive biotechnology, ensuring safety, quality, and innovation in every step.