Regulatory

QUALITY POLICY

It is the policy of Heart Imaging Technologies, LLC, to design and produce products and services that meet or exceed our customer requirements and expectations, and to comply with all statutory and regulatory requirements. We are committed to maintain the effectiveness of the Quality Management System by monitoring our performance against established measurable objectives and through leadership that promotes employee involvement and commitment.

QUALITY MANAGEMENT SYSTEM

Heart Imaging Technologies, LLC maintains ISO 13485 Quality System Certification | Certificate Number 0086717

US FDA (21 CR Part 820) compliance We are fully compliant with the US FDA Quality System Regulation

View our Establishment Registration on the FDA website

NOTIFIED BODY / REGISTRAR / CERTIFICATION BODY

Intertek Testing Services – ISO 13485 Certification

1829 32nd Avenue

Lachine, QC  H8T 3J1

T: +1 514 631 3100

Intertek Testing Services

Intertek Semko AB – CE Certification

Torshamnsgatan 43

Box 1103

SE-164 22 Kista

Sweden

Organization ID: 556024-0599

 

PRODUCT CERTIFICATIONS AND APPROVALS

UNITED STATES – FDA 510(k) cleared/PMA approved devices

WebPAX | 510(k) Number 152949

CANADA – Medical Device Licenses

WebPAX | License Number 99988

EUROPE – CE Marking certificates

WebPAX | Certificate Number CE 4130113494

BRAZIL – ANVISA

WebPAX | Registration Number 80117580706

 

GLOBAL REGULATORY REPRESENTATIVES

Shown below are in-country representatives for regulatory affairs issues and incident reporting.

BRAZIL – Registration Holder

EMERGO BRAZIL, Brasilia, Brazil

T: +55 61 3386 3166

https://www.emergogroup.com/services/brazil/brazilian-registration-holder

EUROPE –  Authorized Representative

EMERGO EUROPE, The Hague, The Netherlands

T: +31 70 345 8570

https://www.emergogroup.com/services/europe/european-authorized-representative

If you require further information on Heart Imaging Technologies’ Quality Management System or the regulatory approval status for Heart Imaging Technologies’ products, please contact

Susan Adams-Judd

Vice President – Business Affairs

Head of Quality Assurance

susan.adamsjudd@heartit.com

+1 919 323 4111