ABOUT ORTOMA
Controllable Treatment Solutions With Cutting Edge Technology
Orthopaedic surgical procedures involve several challenging steps and many technical components. Ortoma’s goal is to improve patients’ lives by developing efficient, innovative products to support surgeons so they can provide the best possible outcome for their patients while keeping them in control of the entire process.
HISTORY
As a True Pioneer
The connection between art, science, and medicine exists since the beginning of time and curiosity is its driving force. Ortoma believes that improving medical science comes with using cutting-edge technology. That philosophy is what inspired Ortoma to develop products to improve the patient’s quality of life. We focus on developing technology solutions for orthopaedics procedures. In 2011, Ortoma initiated the development of a 3D pre-operative planning platform for orthopaedics procedures with hip replacement surgery as the first priority.
MANAGEMENT
– IP Lawyer
– Previously managed the IP department of Nobel BioCare
– Holds an M.Sc. in electrical engineering from Lund University of Technology and a graduate of European Patent Litigation from the Université Robert Schuman (Strasbourg III)
– Served as Medical Imaging Manager, at Nobel Biocare.
– Has published several peer-reviewed scientific articles about the accuracy of 3D planning implants and guided surgery
– Spine Surgeon, holds a M.D. and Ph.D. from University of Gothenburg
– Internationally renowned for his contribution in spine surgery and biomechanics
– Has published almost 200 articles in international peer reviewed medical journals and 30 books
BOARD OF DIRECTORS
– M.D. and Ph.D. from Karolinska Institute
– Chairman of the Board at Stockholm Center for Spine Surgery, Academy and EnCare AB
– Co-founder of one of the largest spine centers in Europe
– Served as Chief Medical Officer, CEO and Vice Chairman at Capio Group
– Served as Independent Chairman of the Board of Swedish Hospital Partners
– Holds an MBA from Frankfurt School of Finance and Management.
– Spine Surgeon, holds a M.D. and Ph.D. from University of Gothenburg
– Internationally renowned for his contribution in spine surgery and biomechanics
– Has published almost 200 articles in international peer reviewed medical journals and 30 books
– Principal owner of Infotech Väst AB, which conducts active development of technology-intensive companies with AI capabilities
– Well known and acknowledged for his achievements as a pioneer in digitizing dentistry
– Built systems including surgical navigation for dental applications that was sold to a Danaher company
– Adj. Professor at Chalmers University of Technology, Gothenburg, Sweden
– Founder and CEO of educational group Baggium AB
– Serial entrepreneur, has founded several business within the financial, construction, and engineering industries
FDA CLEARED, CE CERTIFIED & PMDA CERTIFIED
The Ortoma Treatment
Solution™ is Cleared
Ortoma Treatment Solution (OTS™) for hip replacement surgery, including OTS™ Hip Plan and OTS™ Hip Guide, is CE marked and FDA 510(k) cleared. OTS™ Hip Plan is PMDA certified.
Ortoma Treatment Solution (OTS™) for spine surgery, including OTS™ Spine Plan, is CE marked, and FDA 510(k) application submitted.
ISO 13485 CERTIFIED
Quality Management System
for Medical Devices
Perhaps more than any other product, medical devices’ quality directly impacts their effectiveness and the patient, users, and other people’s safety. Therefore, most national regulatory bodies require medical device manufacturers and suppliers to have an internal quality management system that is independently verified and audited.
Ortoma´s Quality Management System is ISO 13485 certified. The standard specifies requirements for a quality management system of a medical device manufacturer and includes specific requirements concerning e.g. development, production, marketing, distribution, and sale of medical devices. ISO 13485 is similar in scope and intent to ISO 9001 and includes additional requirements specific to medical devices.
Ortoma´s quality management system is also audited and certified as part of the CE certification of Ortoma´s products and is in compliance with applicable requirements in the U.S. 21 CFR820 (QSR) concerning quality management system.