Quality Policy

Aspyra's Quality Policy is to provide our customers with high quality, clinically focused products backed by excellent customer service and support through a commitment to the requirements and effectiveness of our quality management system.

Quality Management System

Aspyra has developed, implemented, and maintains a quality management system to better satisfy the needs of our customers. The quality system, as defined by Aspyra's Quality Manual and supporting quality system procedures, incorporates the applicable essential requirements of the FDA Quality System Regulation 21 CFR: 820, as well as 21 CFR: 801, 21 CFR: 803, 21 CFR: 806, and ISO 13485:2003.

Device Manufacturing License

ASPYRA, LLC successfully completed the annual Device Manufacturing License required by the State of California Public Health Department Food and Drug Branch.  All medical device manufacturers in California are required to annually register with the state and undergo an audit of their quality system carried out by the state’s Food and Drug officers.  The audit confirmed the effectiveness of ASPYRA’s quality system with no audit findings.  ASPYRA is dedicated to providing high quality products to our customers.

Marketing Clearance

The FDA has cleared Aspyra PACS systems for marketing in the USA via FDA 510(k): K091631.

HIPAA, ARRA, and HITECH Compliance

Aspyra is committed to assisting our customers with HIPAA, ARRA, and HITECH regulatory compliance. Security safeguards are incorporated into all Aspyra software to protect the privacy, confidentiality, and integrity of electronic protected health information.