ABOUT ORTOMA
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.
Management
Fredrik strömberg
CEO
- Fredrik Strömberg, M.Sc. in Industrial Engineering and Management Intl. is an experiened leader with very long experienced in MedTech. Over the past 20 years, Fredrik has mainly worked in various leading roles within the global medical device company Nobel Biocare. The roles include work as Senior Director Marketing and Product Management, Senior Regional Director North Europe, as well as Global Head Marketing, Customer Care, and strategic Key Accounts.
Dr. Andreas Pettersson
Head of Clinical Operations
- Ph.D in Medical Science at Karolinska Institutet 2011,
- 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
anna zyla
Head of Operations
- MSc in Management and Production Engineering
Carianne Nilsson
Head of Sales and Marketing
- MSc in Engineering Physics
Hassan Nemati
Head of Technical Research
- Ph.D Signals and Systems Engineering
Fredrik Hedberg
Head of QA/RA
- B.Sc. Mechanical engineering
M.Sc. Sustainable energy systems
Board of directors
Yvonne Mårtensson
Chairman
- Independent board member
- Other assignments include board member of Boule Diagnostics AB and Uniogen OY
- Holds an M.Sc. in Industrial Economics at Linköpings Tekniska Högskola
Prof. Tommy Hansson
Board member and Chief Medical Officer
- Professor emeritus in Orthopedics at the University of Gothenburg
- 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
Roy Forslund
Board Member
- Has a vast experience of developing companies that operate in industries where innovative business models and new technology can contribute to influencing operations to achieve great success
- Principal owner of Infotech Väst AB, which conducts active development of technology-intensive companies with AI capabilities
Peter Möller
Board member
- Independent investor and owner of family office Peroso AB
- Serial entrepreneur, has founded several business within the financial, construction, and engineering industries
Anders Hahn
Board member
- 30 years of experience in the MedTech industry. Currently working as a freelance business specialist in the MedTech industry.
- Previous positions include, among others, roles as Country Manager and Sales Director for Zimmer Biomet, CEO and Business Unit Manager for Biomet Ortopaedics AB.
Marie Aabö
Board member
- Current role as General Manager for the Nordics and Baltics in Electrophysiology at Abbott Medical. Previous experiences include, Regional Business Director for the Nordics and Country Director/CEO for Sweden and Iceland at Medtronic AB.
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 and OTS™ Hip Guide are PMDA certified.
Ortoma Treatment Solution (OTS™) for spine surgery, including OTS™ Spine Plan, is CE marked.
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.