PRESS RELEASE: Osseointegration International successfully maintains ISO and MDSAP certification

Osseointegration International, known for its innovative Osseointegration Prosthetic Limb (OPL) system and its expertise in Osseointegration surgery, has recently undergone a comprehensive assessment by BSI, a prominent International Medical Devices Notified Body, for their annual surveillance audit on ISO 13485 and MDSAP standards.
As a pioneer in orthopaedic surgery for amputees, the company is committed to the highest quality benchmarks. ISO 13485 represents a stringent set of Quality Management System (QMS) standards for companies engaged in the design, production, installation, servicing, and manufacturing of medical devices. Meanwhile, the Medical Device Single Audit Program (MDSAP) streamlines regulatory approval across various jurisdictions, such as Australia, Brazil, Canada, Japan, and the United States, by enabling a single audit of a medical device manufacturer’s quality management system.
This achievement enables Osseointegration International to maintain its presence in an international setting, underlining the company’s dedication to patient-centric innovation and it highlights the combinations of Professor Al Muderis’s surgical expertise with the organization’s technical proficiency.
In a recent stride forward, Osseointegration International launched the innovative OPL Clamp Connector System. This system introduces a tool-less, swift attachment and release mechanism for external prosthetic limbs, vastly enhancing user convenience. Furthermore, its refined adjustable safety pin design serves as a robust safeguard against unforeseen, excessive torsional loads, ensuring heightened durability and reliability for both patients and implants.
Further information about the osseointegration technique, can be found at https://osseointegration.org/, offering insights into its mechanisms, applications, and the transformative impact it promises for amputees on a global scale.
This continued commitment in quality standards and groundbreaking innovations further solidify Osseointegration International’s vision in pioneering advancements in the field of orthopaedic surgery, dedicated to improving the lives of amputees globally.