By establishing clear standards, protocols, and metrics for quality assurance, our QMS not only enhances product and service quality but also cultivates a culture of accountability and excellence. It is maintained by a dedicated Quality team with decades of industry expertise, facilitates compliance with regulatory requirements, and fosters continuous improvement.

Regulatory Affairs

Ozette is dedicated to ensuring our products meet or exceed applicable guidelines, standards, and regulations. Current applicable guidelines, standards, and regulations implemented into Ozette's QMS include:

21 CFR Parts 11, 50, 54, 56, 812, 820 (FDA)
29 CFR Part 1910 (OSHA)
45 CFR Part 164 (HIPAA)
Washington Administrative Code (WAC), WA Dept. of Labor & Industry
WHO GCLP & DAIDS GCLP Guidelines
ICH E6 Good Clinical Practice
GAMP5
IEC 62304
ISO 13485
ISO 14971
ISO 27001
ISO 9001
SOC 2
EU 2016/679 GDPR
Labeling (FDA): The data provided by Ozette is for research/investigational use only, not for use in diagnostic procedures; the performance characteristics of this product have not been established for diagnostic procedures.

Information Security

Ozette's IT infrastructure employs robust industry best practices to ensure the confidentiality, integrity, and availability of customer data. We prioritize information security compliance by implementing encryption protocols, access controls, training, and regular security updates to mitigate potential risks and vulnerabilities.

  • Dedicated information security staff
  • Formal, documented security policies reviewed on a scheduled cadence
  • Company-wide training on security, cybersecurity, and HIPAA/GDPR
  • Strict controls keep customer data separate; access restricted to authorized personnel
  • Data encrypted at rest and in transit
  • Network and wireless connections monitored and controlled
  • Penetration tests and network scans performed regularly
  • Infrastructure hosted by Amazon Web Services with best-in-class security

Compliance & Continuous Monitoring

Continuous monitoring enables our organization to meet regulatory requirements and maintain the highest standards of data protection. Additional details on continuous monitoring of Ozette's security infrastructure are available via our Drata Trust Center. Ozette complies with all legal requirements for handling personally identifiable data, including US HIPAA and EU/UK GDPR.

Data Protection Officer (DPO): Contact dpo@ozette.com for all EU/UK Right to Erasure, Right to Restrict Processing, Right to Data Portability, and Right to Object requests.

EU GDPR Representative

Osano International Compliance Services Limited
ATTN: JYTM
3 Dublin Landings, North Wall Quay
Dublin 1, D01C4E0

UK GDPR Representative

Osano UK Compliance LTD
ATTN: JYTM
42-46 Fountain Street
Belfast, Antrim, BT1-5EF