Published at Wednesday, February 5, 2020 10:28 AM on the Biomech Innovations AG organization's page
Startup of the month @ Swiss Medtech!
Visit the Swiss Medtech website under https://www.swiss-medtech.ch/som
Biomech Innovations AG
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Switzerland, Nidau
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Are you operating in the non-active implantable medical device sector and seeking to accelerate your path to the EU market? We invite you to explore a unique opportunity to partner with or acquire a Swiss Medtech company at the forefront of innovation.
We are ISO 13485 and MDR certified, and we specialize in cutting-edge solutions for traumatology, including our proprietary screw technology that is redefining industry standards. With our strong regulatory foundation and breakthrough technology, we offer a fast track to EU market access and long-term growth potential.
Let’s connect and discuss how our expertise and strategic positioning can support your business goals. We're open to acquisition discussions and collaboration opportunities.
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Published at Friday, January 17, 2020 8:47 AM on the Biomech Innovations AG organization's page
5.0 mm Variable Fixation Locking Screw is CE marked.
Biomech Innovations (BMI) is pleased to announce receiving CE marking approval for its 5.0 mm Variable Fixation Locking Screw. Variable Fixation is the novel locking screw technology based on mechanobiology principles. Variable Fixation Locking Screws provide rigid fixation followed by progressive fracture dynamization, when they matter.
Gradually transitioning from one fixation method to the other, they increase the chance to trigger the fracture healing process and promote the formation of larger amount of bone callus.
Dr. Stefano Brianza, Biomech Innovations’ CEO and founder, commented: “Big leaps in bone fracture treatment have been possible thanks to technological advancement promoting healing after the first surgery and thus reducing the complication and co-morbidity rates. Providing surgeons with innovative, evidence based medical devices is our contribution to advancing traumatology and patient care”.
Implanted with existing surgical techniques and instruments, Variable Fixation is virtually compatible with all locking technologies. BMI starts clinical activity with prestigious academic trauma centres and limited launch in selected EU countries in 2020.
Published at Friday, November 22, 2019 8:10 AM on the Biomech Innovations AG organization's page
ISO 13485:2016 certification
Biomech Innovations today announced that its quality management system (QMS) has been certified by Italcert as ISO 13485:2016 compliant. Italcert is a Milan based notified body with remarkable experience in orthopedics.
Compliant to European and US requirements its scope enables Biomech Innovations to execute on development, manufacturing and distribution activities necessary in order to bring safe and effective medical devices to the European market and later to the US and other international markets.
Stefano Brianza, Biomech Innovations’ CEO and founder, said: “The certification of the quality system is a fundamental milestone for Biomech Innovations. We are very proud to develop our Variable Fixation technology fulfilling current international quality requirements.”
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