Regulatory Compliance

Information Security Compliance

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 to certify our compliance to the ISO 27001:2013 standard.

Intelerad Medical Systems Inc. SOC Report is an independent third-party examination report demonstrating how Intelerad achieves key compliance controls and objectives. The SOC 2 Type II report covers Security and Confidentiality during the November 1, 2022 – September 30, 2023 review period. The scope includes hosting services provided for Intelerad’s products and its subsidiaries. Intelerad’s subsidiaries include Clario, LUMEDX, HeartIT, Ambra and LifeImage. In addition to this review, we are assessing our conformity against HIPAA on a regular basis.

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.

Round badge showing the certification "ISO 27001" for Information Security Management System, with a blue outer ring and stars, and a text banner reading "CERTIFIED" across the center. The bottom part includes text "360 Advanced Compass Rose" and a stylized logo.
This image features the aicpa soc for service organizations seal, indicating certification or recognition in service organization control standards.

Trust Center

You can visit our Trust Center to have access to our latest Information Security certificates and reports. 

Quality Management System

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

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.

Regional Compliance

Regional Compliance Regional Authorities and Local Representation



Authority: Health Canada


Authority: European Commission
Representation: Emergo Europe

New Zealand

Authority: Medsafe
Representation: Emergo New Zealand

Saudi Arabia

United States

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



Other Certificates:

HealthView PACS, HealthView ECG (LUMEDX)