Lake Forest, CA — September 2025 — Biodynamik, Inc. has achieved a major milestone with the successful completion of its Medical Device Single Audit Program (MDSAP) audit and attainment of ISO 13485:2016 certification. These accomplishments demonstrate the company’s commitment to the highest international standards of quality, safety, and regulatory compliance for medical devices.

ISO 13485 is the globally recognized standard for medical device quality management systems, ensuring that companies consistently design, develop, and manufacture products that meet both regulatory and customer requirements. The MDSAP audit also allows Biodynamik to meet the requirements of multiple regulatory authorities, including those in Canada and Australia, through one comprehensive audit process.

“By achieving ISO 13485 and MDSAP, Biodynamik proves that even as a small, fast-growing company, we hold ourselves to the same world-class standards as established industry leaders, demonstrating our readiness to expand internationally and deliver innovations that improve patient outcomes,” said Joe Freeman, Biodynamik’s VP of Operations.

With this certification and audit completion, Biodynamik is now positioned to advance its international commercialization strategy, including upcoming launches in Canada and Australia, where MDSAP compliance is a requirement. These milestones further strengthen the company’s ability to execute on its mission.

About Biodynamik

Biodynamik, Inc. develops orthopedic external fixation systems. The XT3® System is FDA 510(k) cleared for fracture fixation, nonunion, transverse bone transport of the tibia, and the correction of bony or soft tissue defects and deformities in adult patients. Biodynamik is sponsoring the SMILE-TTT study (IDE G260049) of transverse tibial transport in patients with diabetic foot ulcers; this use is investigational.