Intelerad

Système de gestion de la qualité

Les Systèmes médicaux Intelerad a mis en œuvre un système de gestion de la qualité dans le but de mieux répondre aux besoins de nos clients, d’assurer la qualité de nos produits et de nous conformer aux exigences réglementaires. Le système de gestion de la qualité repose sur une politique de la qualité et des objectifs de qualité.

Notre système de gestion de la qualité fait l’objet d’audits périodiques exécutés par un registraire – BSI – pour certifier que nous sommes conforme aux exigences réglementaires de plusieurs pays, comme documenté ci-dessous.

Conformité régionale

 
Autorités réglementaires et représenté par

Australie

Autorités réglementaires: Therapeutic Goods Administration
Représenté par: Emergo Australia

Brésil

Autorités réglementaires: Brazilian Health Surveillance Agency (ANVISA)
Représenté par: Emergo Brazil

Canada

Autorités réglementaires: Health Canada

Europe

Autorités réglementaires: European Commission
Représenté par: Emergo Europe

Nouvelle-Zélande

Autorités réglementaires: Medsafe
Représenté par: Emergo New Zealand

Arabie Saoudite

Autorités réglementaires: Saudi Food and Drug Authority
Représenté par: Emergo Saudi Arabia

E-U

Autorités réglementaires: Food and Drug Administration
Représenté par: OTech, Inc.

Royaume-Uni

Autorités réglementaires: Medicine Healthcare Products Regulatory Agency (MHRA)
Représenté par: Emergo UK

Exigences réglementaires

IntelePACS


Afrique du Sud – Added to a local representative licence
Australie – Australian Register of Therapeutic Goods
Canada – Medical Devices Active Licence Listing (MDALL) and Establishment Licence Listing (MDEL)
E-U – Establishment Registration & Device Listing and 510(k) Premarket Notification
Europe – EC Certificate
Nouvelle-Zélande – New Zealand Web Assisted Notification of Devices (NZ WAND)
Autres exigences:

ISO 13485:2016
MDSAP

HealthView PACS, HealthView ECG (LUMEDX)


Arabie Saoudite – Medical Device Marketing Authorization
Australie – Australian Register of Therapeutic Goods
Canada – Medical Devices Active Licence Listing (MDALL) and Establishment Licence Listing (MDEL)
E-U – Establishment Registration & Device Listing and 510(k) Premarket Notification
Europe – EC Certificate
Autres exigences:

ISO 13485:2016
MDSAP
ISO 27001


Doctors Review System (Digisonics)


E-U – Establishment Registration & Device Listing and 510(k) Premarket Notification
Autres exigences:

ISO 9001


WebPAX (HeartIT)


Arabie Saoudite – Medical Device Marketing Authorization
Australie – Australian Register of Therapeutic Goods
Brésil – BHRA Registration
Canada – Medical Devices Active Licence Listing (MDALL) and Establishment Licence Listing (MDEL)
E-U – Establishment Registration & Device Listing and 510(k) Premarket Notification
Europe – EC Certificate
Autres exigences:

ISO 13485:2016
MDSAP


Insignia


Europe – EC Certificate
Autres exigences:

ISO 13485:2016

 

Ambra ProViewer / DG PACS (Ambra)

  • États-Unis – Enregistrement de l’établissement & Liste des dispositifs et notification préalable 510(k) (K231360 pour ProViewer / K152977 pour DG PACS)

Autres certificats:

Information Security Management System ​

Intelerad has implemented an Information Security Management System (ISMS) to better protect the information it possesses, processes or has access to and to comply with its customers’ confidentiality requirements. records of their patients.

Our SGSI is subject to periodic audits carried out by a registrar –  BSI  – in order to certify our compliance with the requirements of the  ISO 27001:2013* standard .

Document compliance

We maintain our system compliance with industry standards, therefore HIPAA, DICOM, HL7 and IHE.

IntelePACS/InteleViewer

(*) Available only in English version.

LUMEDX/HealthView

Quality policy

“We at Intelerad, a provider of distributed medical imaging solutions, understand that our success depends on the satisfaction of our customers. We aim to satisfy our customers by meeting their requirements, training our staff, maintaining the effectiveness of our quality management system and complying with regulatory requirements. »

Information Security Policy

“Intelerad understands that information security is an important issue in a world where threats and technologies are rapidly evolving. To meet this challenge, Intelerad has adopted an ISMS certified under the international standard ISO 27001 and this information security policy. Intelerad’s ISMS is the vehicle for continuous improvement in information security. Intelerad is committed to protecting patient data to which Intelerad has access and ensures the confidentiality, veracity and availability of this data by complying with Federal and international laws as well as standards relating to information security, specifically HIPAA , ISO 27001, SOC 2 as well as by continually reviewing and improving its performance in this area. »