Commitment to International Regulatory Standards & Product Safety
As a global leader in spine and orthopedic medical devices, Orthofix is dedicated to maintaining the highest level of corporate integrity, product safety, and regulatory compliance. Overseas healthcare buyers, hospital procurement teams, and international distributors rely on our robust Quality Management Systems (QMS) designed to meet strict market entry and safety guidelines worldwide.
Our manufacturing and operational processes comply with United States Food and Drug Administration (FDA) Quality System Regulations (21 CFR Part 820), European Union Medical Device Regulation (EU MDR 2017/745), and ISO 13485 international certification standards for medical devices.
Global Quality Certifications & Regulatory Approvals
Every orthopedic implant, spinal fusion cage, external fixation system, and therapeutic device developed by Orthofix undergoes rigorous quality assurance testing, biocompatibility verification, and mechanical validation prior to global commercial distribution.
Ethical Business Conduct & Industry Codes of Practice
Orthofix actively supports ethical interactions between medical technology companies and healthcare professionals (HCPs). We believe transparent medical collaboration ensures clinical decisions are strictly guided by patient outcome quality. Our business practices strictly align with major global industry ethical guidelines:
- AdvaMed Code of Ethics: Rigorous adherence to Advanced Medical Technology Association guidelines for ethical commercial and educational interactions in the United States and global markets.
- MedTech Europe Code of Ethical Business Practice: Full compliance with European medical device industry standards for third-party educational grants and HCP collaboration.
- Confindustria Dispositivi Medici: Adherence to Italian and European transparency standards for medical device distribution and HCP payment disclosures.
- Abimed & Abraidi Standards: Compliance with South American medical device distribution regulations and commercial ethics codes.
Corporate Governance & Transparency Reporting
Orthofix complies with global financial and transfer of value transparency requirements, including the US Physician Payments Sunshine Act and state-level compliance mandates such as California Health & Safety Code ยง 119402. Annual written declarations of compliance and transparency disclosures demonstrate our commitment to ethical accountability across every international market we serve.
In addition, Orthofix holds an EcoVadis sustainability rating, validating our environmental management practices, human rights standards, sustainable procurement pathways, and ethical corporate governance for international supply chains.
Comprehensive Quality Management & Whistleblower Protection
Our Organization, Management, and Control Model (including Legislative Decree 231 and EU Directive 2019/1937 compliance) ensures that all employees, commercial partners, and international distributors operate under unified compliance guidelines. We maintain an independent, 24/7 confidential reporting system (EthicsPoint) enabling any stakeholder to report potential policy deviations without fear of retaliation.