PRESS RELEASE: LifeSync Robotics receives ISO 13485:2016 Medical Devices Quality Management Systems Certification

SINGAPORE, October 28, 2024 -- LifeSync Robotics is pleased to announce that the company has been awarded ISO 13485:2016 certification for Design, Manufacture and Sales of Surgical Navigation and Robotic Guidance System by SGS, demonstrating its adherence with the most rigorous global regulatory and quality standards. ISO 13485 is the harmonized standard for quality management systems in the design and manufacture of medical devices. It outlines specific requirements that help organizations ensure their medical devices meet both customer and regulatory demands for safety and efficacy.

“We are proud of the robust systems and processes on design and manufacturing our team has set up from day one as the manifestation of our insistence on safety and compliance,” said Wilson Fok, co-founder of LifeSync Robotics responsible for R&D and manufacturing. “This certification demonstrates our ongoing ability to meet exacting regulatory requirements as we continue to achieve clinical and developmental milestones for our autonomous surgical solutions.”

“We are really excited about the doors this opens for us as a company and the strong position it puts us in on obtaining medical device registration in Singapore, Thailand and Malaysia by 2025,” says Fong Lau, co-founder of LifeSync Robotics responsible for marketing and sales. “But most importantly, we are delighted to show our partners the readiness of our technology and that we have built a quality, effective and safe platform of solutions to aid in surgical procedures.”

ISO 13485 is crucial for manufacturers and suppliers of medical devices as it establishes a framework to ensure consistent design, development, production, and delivery of medical devices that are safe for their intended purpose. It aids in meeting rigorous regulatory requirements and managing risk, while ensuring best practices in the manufacture of medical devices. This standard not only facilitates market access across different countries but also enhances trust among stakeholders through demonstrated commitment to safety and quality.

About LifeSync Robotics

Founded in Singapore, LifeSync Robotics provides autonomous surgical solutions for ASEAN countries. LifeSync Robotics’ flagship product, Asclepius, is a orthopedic surgical robot that provides AI automatic surgical planning, dynamic patient position tracking and auto-correction with force control and force feedback technology, and supports autonomous K-wire placement and human-machine collaboration. Asclepius can be used in all orthopedic surgeries including spine, hip, knee and trauma. In addition to proprietary intellectual properties that reduce costs associated with the robotic arm, the built-in technology contained in Asclepius also enables it to be used with a variety of imaging systems, therefore providing customers with a choice of solutions at different price points. Asclepius is expected to complete medical device registration in Singapore, Thailand and Malaysia by 2025.

LifeSync Robotics may be reached at enquiry@lifesyncrobotics.com or www.lifesyncrobotics.com.