Regulatory
Compliance

Quality Management System

Intelerad has implemented a Quality Management System (QMS) to better satisfy our customers’ needs, ensure product quality and regulatory compliance. This Quality Management System is driven by a quality policy and quality objectives.

Our QMS is regularly audited by a registrar – BSI – to certify our compliance to various countries requirements as documented below.

Regional Compliance

Regional Compliance Regional Authorities and Local Representation

Australia

Canada

Authority: Health Canada

Europe

Authority: European Commission
Representation: Emergo Europe

Saudi Arabia

United States

Authority: Food and Drug Administration
Representation: OTech, Inc.

Certification/Registration

Doctors Review System (Digisonics)

 

InSight PACS (Insignia)

 

Ambra ProViewer / DG PACS (Ambra)

  • United States – Establishment Registration & Device Listing and 510(k) Premarket Notification (K202335 for ProViewer / K152977 for DG PACS)

Information Security Management System

Intelerad has implemented an Information Security Management System (ISMS) to better protect the information it owns, handles or has access to and to meet the confidentiality requirements of our customers with respect to their patient information.

Our ISMS is regularly audited by a registrar – BSI – to certify our compliance to the ISO 27001:2013 standard. Our Hosting Services are also SOC 2 Type II certified. We are also assessing our conformity against HIPAA on a regular basis.

 

Conformance Documents

We maintain our system conformance with industry standards, including DICOM, HL7, and IHE.

 

IntelePACS/InteleViewer

 

LUMEDX/HealthView

 

WebPAX (HeartIT)

 

InSight (Insignia)

 

Ambra ProViewer (Ambra)

Quality Policy

“We, at Intelerad and subsidiaries, provider of innovative medical imaging solutions, understand that our success depends on the satisfaction of our clients. We are committed to quality and technology leadership by providing reliable and superior products that meet or exceed the requirements of our customers and regulatory agencies, backed by an organization committed to compliance, continuous improvement, and patient safety."

Information Security Policy

“Intelerad is aware that information security is an important challenge due to fast-evolving threats and technologies. In response to this challenge, Intelerad implemented an ISMS under an ISO 27001 certification and this Information Security Policy. Intelerad’s ISMS is a way to keep improving the company’s information security. Intelerad shall protect all client PHI that Intelerad has access to and ensure the confidentiality, integrity and accessibility of such data, by complying with Federal and international laws regarding information security, particularly HIPAA, ISO27001, SOC 2 and by continually reviewing and improving its performance in this area. This Policy applies to all users, whether they are, temporary or permanent employees, managers, administrators or subcontractors.”