Swiss MedTech Startup, Ozics Group, Receives ISO 13485:2003 Quality Management System Certification

Sept. 16, 2011 - PRLog -- Swiss MedTech Startup, Ozics Group, Receives ISO 13485:2003 Quality Management System Certification from Notified Body

Validation Underscores Medical Device Startup’s Commitment to Quality Performance


Ozics Group (www.ozics.com), a Swiss medical device startup company which develops and manufactures minimally invasive fracture fixation systems to be used in load bearing fractures, announced today that it has received the International Organization for Standardization (ISO) 13485:2003 certificate for the "design, development, manufacture and distribution of bone cements, non-active orthopaedic implants and accessories for the treatment of orthopaedic and spinal trauma." The company is currently developing a family of surgical implants to first address the shortcomings in the treatment of vertebral compression fractures (VCF) and screw purchase problems in osteoporotic bone.
“design, development, manufacture and distribution of bone cements, non-active orthopaedic implants and accessories for the treatment of orthopaedic and spinal trauma.”

ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and regulatory requirements.
"Receiving the ISO 13485 certification bears testimony to the company’s ability and commitment to provide patients with safe, high quality products, starting right from the product design and development stage. We are very proud of this achievement as it’s a major milestone for any company but especially for a startup company,” stated Dr. Auvo Kaikkonen, CEO of Ozics.

Ozics Group’s quality review was performed by 3EC (www.3ec.sk), an international certification organization, based in Bratislava, Slovakia.

About Ozics:
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.


Contacts
Ozics Group

Auvo Kaikkonen, CEO
+41 715
770 050
auvo.kaikkonen@ozics.com
www.ozics.com