Compliance

Quality Policy

UltraLinq Healthcare Solutions is a quality driven, customer centric company, committed to providing clinically relevant innovative medical software and device solutions. The organization measures itself on meeting and exceeding customer expectations while consistently demonstrating a positive quality driven culture through teamwork, passion, and integrity within its working environment. The organization is committed to complying with all regulatory requirements and to maintaining the effectiveness of its quality management system.

Here are some of the standards and certifications our company maintains:


FDA 510(k)

UltraLinq is cleared by FDA as a Class II Medical Device. Learn more about our filing here. UltraLinq Healthcare Solutions operates a quality system compliant to 21 CFR 820.


CE Mark

UltraLinq is CE marked as a Class I medical device.


ISO Certification

UltraLinq Healthcare Solutions has been accredited to EN ISO 13485.2012. ISO 13485 specifies requirements for quality management systems in which an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet regulatory requirements and customer requirements applicable to medical devices and related services. Learn more here.


HIPAA

At UltraLinq, HIPAA compliance is at the core of everything we do. From a process standpoint, this includes establishing business associate agreements (BAA) with all customers and vendors, training all employees on security protocols, conducting an annual security risk analysis, and implementing a risk management plan. Here’s a brief overview of some of our technical, administrative, and physical safeguards:


Technical

UltraLinq utilizes Electronic Security Measures and Access Controls (user permissions, new user activations). AES 256-bit encryption and Transport Layer Security (TLS) are used for all data transmission. Data is encrypted in transit and at rest.


Administrative

User Management: UltraLinq is an entirely permission-based system with client configurable, role-based user accounts and access levels. Audit trail and logging: All access, use, and disclosure of patient data is logged and such information can be exported from UltraLinq at any time.


Physical

UltraLinq's data center partner (Amazon Web Services) provides hosting in SOC-audited facilities. Audit reports are available upon request, and further information is available here. Our data center partner is FedRAMP compliant, following NIST and FISMA defined control standards.