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.