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 0073715-00

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

BSI – CE Marking Certificate Kitemark Court
Davy Avenue
Knowhill, Milton Keynes MK5 8PP
T: +44 20 8996 9001
British Standards Institution

 

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 643954

AUSTRALIA – ARTG 
WebPAX | ARTG Number 303060

BRAZIL – ANVISA
WebPAX | Approval Pending

 

GLOBAL REGULATORY REPRESENTATIVES

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

AUSTRALIA – Sponsor EMERGO AUSTRALIA, Sydney, Australia T: +61 2 9006 1662 https://www.emergogroup.com/services/australia/australia-tga-sponsor

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