ForSight Robotics Achieves ISO 13485:2016 Certification

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Biotechnology Surgery Health Optical Health Technology

Internationally recognized certification demonstrates ForSight’s commitment to excellence and progress toward regulatory milestones

ForSight Robotics Achieves ISO 13485:2016 Certification

Adah Forer
ForSight Robotics
adah@forsightrobotics.com

ForSight Robotics, the pioneer in ophthalmic robotic surgery, announced today its achievement of ISO 13485:2016 certification, an international benchmark for quality management systems in the medical device industry. By achieving this certification, ForSight demonstrates its commitment to designing, developing and manufacturing a robotic surgical system and microscope intended for use in ophthalmic surgical procedures.

“Achieving ISO 13485:2016 certification is a testament to our unwavering commitment to quality and regulatory excellence,” said Dr. Joseph Nathan, ForSight Robotics’ co-founder, president, and Chief Medical Officer. “This milestone not only reinforces confidence in the ORYOM™ Platform but also validates the rigorous processes we have in place as we advance toward patient trials and future regulatory approvals.”

This latest certification enhances ForSight’s ability to meet stringent regulatory requirements while reinforcing its dedication to continuous improvement. As the company scales, it remains focused on delivering the highest levels of quality, safety, and innovation in ophthalmic robotic surgery.

The ISO 13485:2016 standard specifies the requirements an organization needs to demonstrate for a quality management system (QMS) that is consistently able to provide medical devices and related services that meet both customer and regulatory requirements. This includes a focus on the design, development, and production of medical devices. The standard emphasizes the importance of risk management and design controls, ensuring that organizations establish, implement, and maintain effective processes that address safety, reliability, and quality throughout the product lifecycle.

About ForSight Robotics Ltd.:
ForSight Robotics is a surgical robotics company pioneering world-class technology to democratize quality surgical eye care. The Israel-based company is developing the ORYOM™ Platform (“daylight” in Hebrew), the world’s first robotic surgery platform for cataracts and widespread eye diseases, which will utilize AI-based algorithms, advanced computer vision, and micromechanics. Backed by globally recognized VCs and industry leaders, ForSight Robotics is redefining ophthalmic surgery and bringing hope to millions of patients worldwide. To learn more, visit forsightrobotics.com and follow us on LinkedIn.

“This milestone not only reinforces confidence in the ORYOM™ Platform but also validates the rigorous processes we have in place as we advance toward patient trials and future regulatory approvals.”