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Conformance statements & resources

RamSoft takes standards compliance very seriously, and we follow strict quality assurance protocols when developing our products to exchange, integrate, share, and retrieve patient data from third-party vendors. See below for our conformance statements and resources.

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POWERSERVER®

PowerServer conformance & technical documents

  • PDF — v6.7 RamSoft Client Integration Specification View
  • PDF — v6.1 MDS² Manufacturer Disclosure Statement for Medical Device Security View
  • PDF — v6.0 IHE Statement — PowerServer Lite, Gateway Viewer View
  • PDF — v6.0 IHE Statement — PowerServer PACS, PowerServer Tele Lite, Gateway Mammo Viewer View
  • PDF — v6.0 IHE Statement — PowerServer RIS/PACS View
  • PDF HIPAA Compliance Statement View
  • PDF — v6.0 Health Canada License (Class II) View
  • PDF — v6.7 DICOM Conformance View
  • PDF — v6.0 HL7 Conformance View
  • PDF — v6.7 Platform Specifications View
  • PDF FDA 510(k) Clearance — K052460, K141881 View
  • PDF RamSoft MACRA Resource View

OMEGAAI®

OmegaAI conformance documents

POWERSERVER — SPEECH UNDERSTANDING

Speech Understanding resources

Information transfer resources

External reference for practice management and informatics teams.

View ACR Practice Management Quality Informatics Reference Guide

STANDARDS & ACCREDITATIONS

Built on rigorous compliance standards

HIPAA (1)

HIPAA Compliant

Patient data handled per the U.S. Health Insurance Portability and Accountability Act.

SOC (1)

AICPA SOC

Independently audited service-organization controls covering security and availability.

FDA 510k (1)

FDA 510(k) Cleared

Cleared as a medical device by the U.S. Food and Drug Administration (K052460, K141881).

PIPEDA (1)

PIPEDA

Compliant with Canada's Personal Information Protection and Electronic Documents Act.

CDMR (1)

CDMR

Health Canada Medical Device Regulations — Class II licensed.

icsa-labs-certified-logo

ICSA Labs Certified

Independent third-party security certification for healthcare information systems.

IHE (1)

IHE

Integrating the Healthcare Enterprise — interoperability profiles for radiology and IT.

TÜV SÜD (1)

TÜV SÜD

Global certification for quality management and medical device safety standards.

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