Compliance
Where Ethics, Integrity, and Patient Safety Come First.
At OX BioMed, compliance is more than a set of rules—it’s a core part of who we are. We are committed to doing the right thing, the right way, every day. Our approach to compliance is rooted in ethics, integrity, and transparency, and guides how we operate, make decisions, and serve providers, patients, and partners.
We uphold the highest standards for safety, quality, and regulatory excellence to ensure that trust—earned from healthcare professionals, patients, and regulators alike—remains the foundation of our reputation. By embedding compliance into our culture and daily practices, we create an environment where accountability, respect, and doing what’s right are second nature.
Regulatory Standards & Oversight
We adhere to all applicable laws and regulations governing human tissue products and biologics. This includes compliance with:
- U.S. Food and Drug Administration (FDA) regulations under 21 CFR Part 1271
- The American Association of Tissue Banks (AATB) standards
- HIPAA and patient data privacy requirements
- CMS billing and reimbursement guidelines
Our facilities and processes are routinely audited to ensure continued alignment with federal, state, and industry-specific regulations. We maintain all relevant state tissue bank licenses where required.
Code of Business Conduct and Ethics
Our Code of Business Conduct and Ethics (the “Code”) outlines the principles that guide our decisions, actions, and relationships by and with our employees, providers, partners, and regulators. It reflects our unwavering commitment to honesty, fairness, respect, and accountability. The Code applies to all employees and third parties who represent Ox BioMed, ensuring that everyone who acts on our behalf does so with transparency, professionalism, and in full alignment with our mission to assist clinicians deliver better care with less friction.
We are equally committed to fostering a culture where concerns can be raised openly and addressed responsibly. Individuals are encouraged to speak up about suspected misconduct, violations of the Code, or unethical behavior—without fear of retaliation. Raising a concern is not only supported but expected. Accountability starts with awareness, and maintaining our high standards depends on all of us.
Certifications & Licenses
OX BioMed is registered with the FDA and licensed/registered as a tissue bank with the states below:
FDA Registration
California Tissue Bank License
Delaware Tissue Bank Registration
Illinois Tissue Bank Registration
