Validation Underscores Medical Device Startup’s Commitment to Quality Performance
St. Gallen, Switzerland
Ozics Group (www.ozics.com)
“design, development, manufacture and distribution of bone cements, non-active orthopaedic implants and accessories for the treatment of orthopaedic and spinal trauma.”
ISO 9001:2008 is a set of quality practices that ensures the use of effective processes that are consistently monitored and continually improved. As the industry standard for quality management systems, ISO 9001:2008 certification requires evaluation by an independent, accredited auditing body.
"Our focus on continued process sets the basis for consistency and efficiency, which our customers to have their lines of communications open across the world,” said Dr. Auvo Kaikkonen, CEO, Ozics. “Obtaining ISO certification demonstrates Ozics’ commitment to deliver a high level of service today and in the future.”
Ozics Group’s quality review was performed by 3EC (www.3ec.sk)
Ozics vision is to develop a range of materials and implants that deliver the clinical benefits outlined above. The basic material is a composite of a dimethylacrylate based polymer matrix and ceramic filler, containing silicateglass and hydroxyapatite (HA). The material can be administered by injection to provide a custom-made, intra-bony implant. Used primarily as a stand-alone device, it can also be used in conjunction with other fixation approaches and devices. Ozics’ first product offering, CompO6™ reinforced bone composite, is an injectable bone cement indicated for vertebral compression fractures and to aid screw purchase in trauma procedures throughout the entire skeleton. Ozics is determined to bring to the market a minimally invasive fracture fixation system to be used in load bearing fractures, such as hip, as a stand-alone device allowing immediate unassisted mobility.
Auvo Kaikkonen, CEO
+41 715 770 050