Certifications and Compliance

BioT is dedicated to upholding the highest standards in quality, security, and compliance. Our certifications reflect our commitment to excellence and our rigorous processes to ensure customer trust and satisfaction.

• Quality Management System: ISO 13485 certified.
• Information Security Management System: ISO 27001 and ISO 27799 certified.
• Cybersecurity and Privacy: Conforms to both US HIPAA and EU GDPR standards.
• HITRUST CSF Certified (v11.4.1 r2): Meets HITRUST’s tailored, risk-based control framework for information security maturity and compliance.
• SOC 2 Type II Certification: Meets American Institute of Certified Public Accountants' Trust Services Criteria (Security, Availability, Processing Integrity, Confidentiality, and Privacy).
• IEC 62304 Compliance: BioT provides an IEC 62304 Design History File (DHF).
• Payment Card Industry Data Security Standard (PCI/DSS): Successfully reviewed by external auditors.

Our commitment to security extends beyond certifications:

Regular Penetration Testing: Partnering with top cybersecurity auditing firms, we conduct routine penetration tests to identify and address vulnerabilities.

Proactive Security Measures: We maintain an always-up-to-date system, continuously improving to mitigate real-world cyber attacks and vulnerabilities uncovered through testing.