Regulatory

Quality Policy

We endeavor to constantly innovate and improve the cardiovascular imaging software and clearly understand the ever-changing needs and requirements of physicians worldwide. We strive to serve them with clinical tools that provide for the best possible outcomes.

Through adherence to, and improvement of, our Quality Management System we continuously strive to be the leader in our industry, providing value added products for healthcare institutions worldwide, guided by our core values of trust, compliance and regard for the stakeholders.

To achieve this we will;

  1. Ensure that our product and quality system is in conformance with the applicable standards and regulatory requirements
  2. Ensure that the product meets its stated or implied specifications
  3. Understand the requirements of the customers and act upon their concerns
  4. Involve employees at all levels of the organization

Regulatory Information

Circle Cardiovascular Imaging Inc. holds globally recognized ISO 13485:2003 certifications from prestigious British Standards Institution (BSI). This certification includes Standards Council of Canada (SCC) endorsement under Canadian Medical Device Conformity Assessment System (CMDCAS) scheme. In addition to ISO 13485:2003, the company quality system is established and maintained to comply with European Medical Device Directive 93/42/EEC, Australian Therapeutic Goods (Medical Devices) Regulations and US FDA Quality System Regulations, 21 CFR Part 820.

Circle Cardiovascular Imaging software development process is following the ANSI/AAMI/IEC 62304:2006 Medical device software – Software life cycle processes and associated standards and guidance documents. An intensive risk management process based on EN ISO 14971:2012 and AAMI TIR 32:2004 Medical device software risk management is in place to capture the potential risks and mitigate such risks as a part of the development process.

cmr42 has received market clearance from Health Canada, US FDA, Australian TGA, European Union, Brazilian ANVISA, and South Korean KFDA.

ct42 has received market clearance from Health Canada & US FDA, Brazilian ANVISA. Approval from European Union, Australian TGA and South Korea FDA are pending.

Click the links provided below to download each document as specified below.

cvi42® is a Software Suite where ct42 and cmr42 functionality is integrated to a single general user interface (GUI).

If you require further information on Circle's Quality System or the regulatory approval status for Circle products, please contact the following:

Dr. Shirantha Samarappuli
Vice President – Regulatory Affairs and Quality Assurance.

Email: shirantha@circlecvi.com
Phone: +1 403 338 1870
Fax: +1 403 338 1895