Quality Policy

UltraLinq Healthcare Solutions is a quality driven, customer centric company, committed to providing innovative medical software. The organisation 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

We take security and protection of patient data very seriously at UltraLinq. We have received certification for ISO27001:2013, the internationally recognized best practice framework for Information Security Management Systems (ISMS), providing assurance that our networks, organization, services and information security systems are safe, monitored and diligently maintained.

UltraLinq Healthcare Solutions has also been certified to ISO 13485.2016. ISO 13485:2016 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

UltraLinq fully complies with the Health Insurance Portability and Accountability Act (“HIPAA”) that governs the use and sharing of personal health information. HIPAA requires that individuals remain in control of their health information at all times, which means, UltraLinq cannot and does not send information without authorization. UltraLinq endorses the security standards raised by HIPAA and we are committed to enabling our customers to protect patient privacy. Privacy and security are essential components of our software solutions.

DPA

At UltraLinq, DPA 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, mplementing a risk management plan. Here’s a brief overview of some of our technical, administrative, and physical safeguards:

  • Technical safeguards– 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 safeguards – 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 safeguards – The UltraLinq data centre partner (AWS) is an NHS Health & Social Care accredited N3 Service Provider and provides hosting in ISO 27001 Information Security Management System (ISMS) certified, UK Tier 3 Standard facilities.

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