Avreo Regulatory Affairs
Quality Policy
We at Avreo, Inc. are committed to Quality. Our commitment requires our dedication to and involvement in Continuous Improvement.
It is our policy to develop, produce, and deliver products and solutions that consistently satisfy our customers. We will continually strive for right-the-first-time performance.
Profitable business performance and excellent quality performance are complementary and consistent objectives.
Compliance
- Substantial Equivalence has been determined by the FDA and accordingly, Avreo is cleared for marketing in the USA. FDA 510(k): KO70755.
- Avreo, Inc. maintains an ISO13485 compliant quality management system.
DICOM Conformance
HIPAA
Avreo is committed to helping our customers comply with the HIPAA Regulations. All Avreo software has security safeguards to protect the privacy, confidentiality, and integrity of the electronic protected health information it receives. In addition, Avreo requires its employees to maintain the confidentiality of all patient files and related information.
