Compliance, Ethics, and Anti-Corruption Statement

Last updated: March 2, 2026

Our Commitment

We are committed to conducting business with integrity, transparency, and respect for applicable laws and ethical standards in every jurisdiction where we operate. As a developer of Software as a Medical Device (SaMD) and clinical decision-support solutions, we recognize that trust, patient safety, and regulatory compliance are foundational to our mission. Our governance framework integrates regulatory, quality, security, and ethical controls to ensure our products and business practices meet the expectations of healthcare providers, regulators, and strategic partners.

Regulatory and Quality Compliance

Our products and development processes operate within a structured electronic Quality Management System aligned with EU Medical Device Regulation (MDR), US FDA requirements under 21 CFR including Part 820 and relevant software lifecycle expectations, and applicable post-market surveillance, risk management, and clinical evaluation requirements.

Our QMS includes documented procedures governing design controls and software lifecycle management, risk management and clinical safety monitoring, supplier qualification and oversight, incident reporting and corrective actions, and continuous improvement processes. These controls ensure that compliance is embedded in both product design and operational practice.

Anti-Corruption and Ethical Business Conduct

We maintain a zero-tolerance policy toward bribery, corruption, or improper influence in any form. We prohibit offering, requesting, or accepting bribes, kickbacks, or facilitation payments; improper inducements to healthcare professionals or customers; undisclosed conflicts of interest in procurement or contracting; and any attempt to gain unfair commercial advantage through unethical means. These standards apply to all employees, contractors, agents, and partners acting on our behalf globally.

We expect third parties working with us to adhere to equivalent ethical standards and applicable anti-corruption laws, including the US Foreign Corrupt Practices Act and relevant European legislation.

Interactions with Healthcare Organizations and Professionals

As a clinical software provider, we ensure that all interactions with healthcare organizations, clinicians, and research partners are based on legitimate clinical, scientific, or operational value; documented through formal agreements; appropriately compensated at fair market value when applicable; and compliant with transparency and disclosure requirements. We do not provide incentives tied to product selection, clinical decisions, or reimbursement outcomes.

Data Protection, Security, and Patient Trust

We maintain safeguards to protect patient data, customer information, and intellectual property through role-based access controls and security monitoring, secure software development practices, vendor and infrastructure risk assessment, and incident response and notification procedures. Our security and privacy practices are aligned with relevant US and European data protection obligations and healthcare confidentiality expectations.

Reporting Concerns and Non-Retaliation

We encourage employees, partners, and customers to report concerns regarding compliance, safety, or ethical conduct. Reports may be made confidentially through designated company channels. We prohibit retaliation against anyone who raises concerns in good faith. All reports are reviewed, investigated where appropriate, and addressed through corrective and preventive actions.

Oversight and Continuous Improvement

Executive leadership maintains responsibility for oversight of compliance, quality, and ethical conduct. We periodically review our policies, training, and controls to ensure they remain effective and aligned with evolving regulatory expectations and industry best practices.

Contact

For compliance inquiries, due-diligence requests, or policy documentation, please contact: regulatory@algodx.com.