PRESS RELEASE: Osseointegration International Receives Medical Device Single Audit Program (MDSAP) Certification

Latest Press Release

Osseointegration International the leading osseointegration implant manufacturer, announces the successful certification of its quality processes by the Medical Device Single Audit Program (MDSAP). The program is aimed at enhancing the safety and quality oversight of medical devices on a global scale.

The MDSAP is a scheme of the International Medical Device Regulators Forum (IMDRF) and was created to streamline the auditing and monitoring of medical device quality management practices across international boundaries. After an extensive evaluation process, Osseointergration International has been granted certification, underlining its dedication to upholding the highest industry standards and advancing outcomes for amputees.

The MDSAP allows accredited Auditing Organisations to conduct a single regulatory audit that fulfils the requirements of multiple regulatory authorities participating in the program. Osseointegration International’s successful participation in this program reflects its commitment to efficient compliance and its ability to meet the stringent standards set by regulatory bodies worldwide.

Participation in the MDSAP involves collaboration with international partners, including regulatory authorities and observing organizations from various countries. Notable members of the program include the Therapeutic Goods Administration of Australia, Brazil’s Agência Nacional de Vigilância Sanitária, Health Canada, Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency, and the U.S. Food and Drug Administration.

Professor Munjed Al Muderiis, the company’s founder, commented: “This certification marks a significant milestone for us. It demonstrates our commitment to global excellence, innovation, and patient safety. By streamlining the auditing process and adhering to international standards, we can deliver in a way that meets the expectations of regulatory bodies and, more importantly, patients around the world.”

Media Contacts:

Name: William LuCompany: Osseointegration InternationalEmail: [email protected]Phone: +61 2 8882 9011

Attachments:

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September 1, 2023/by Reland Pigte

About Osseointegration International

Osseointegration International designs and markets the Osseointegration Prosthetic Limb System (OPL). The OPL system is made up of multiple components. The core implant is made of high-tensile strength titanium with a highly porous titanium coating, providing both initial stability as well as long-term bone integration (in-growth). The unique properties of the titanium coating allow the bone to grow into the surface of the prosthesis, which makes the bone-implant structure one solid unit.

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