Quality Management System Certifications

Quality leading to patient safety and user satisfaction is an integral part of Formus. We pride ourselves on combining modern product development best-practices with an effective, fit-for-purpose quality system which allows us to rapidly innovate while meeting international regulatory requirements.

We have been operating under a certified ISO 13485:2016 quality management system since 2020. To support our global ambitions, in 2023 we received our initial certification under the Medical Device Single Audit Program (MDSAP) to include Australia, Canada, United States, and Japan.

We are committed to continuously improving our quality management system to ensure that we continue to meet customer needs and changing international regulatory requirements.

Our processes are routinely audited to ensure that our quality management system continues to be effective and meet applicable requirements.

Formus Hip, our pre-operative planning software for total hip arthroplasty, has regulatory licences and clearance in New Zealand, Australia and USA.