Formus Labs is proud to announce that we have recently been awarded ISO 13485 certification, following the successful completion of our Stage 2 quality systems audit. This represents a significant step toward achieving regulatory approval in international markets, with ISO certification a core requirement across key territories.
ISO 13485 has been noted as being the “world’s most popular standard for medical device quality management”, serving as a prerequisite for launching in territories such as Australia, Brazil, Canada, Japan, and the USA. Notably, the FDA has recently announced that ISO 13485 certification will serve as the basis for its quality system legislation moving forward.
“As a company with global ambition, achieving the ISO standard is a crucial building block in our product development and regulatory road map. These standards are of the highest order, designed to protect end-users and ensure a quality product output. We’re pleased to be able to confidently say that the Formus platform stands up to this widely-accepted international benchmark”, affirmed Formus CEO, Dr. Ju Zhang.
The adoption of ISO 13485 by the FDA, as part of its stated drive toward a global convergence of medical device regulatory processes, further solidifies the importance of ISO certification for global markets. Part of achieving these standards involves putting effective processes in place to receive and act upon user feedback, toward the goal of optimizing both the safety and efficacy of our product. We remain committed to continuously improving the platform and are proud to receive this external validation of our approach.
The goal of the Formus platform has always been to be used by any surgeon, in any hospital, anywhere in the world. With the achievement of this international certification, paired with our commitment to improvement, we are closer than ever to making this a reality.