v3.4.0 FDA/Health Canada/TGA for US, Canadian, Australian and EU Customers

• Installation Guide
• User Manual
• Release Notes
• DICOM Conformance Statement
• MDS2 - Manufacturer's Disclosure Statement
• Terms & Conditions (EULA)

Archives

Compliance Information

Circle Cardiovascular Imaging Inc. holds globally recognized ISO 13485:2016 and MDSAP certificates from the British Standards Institution (BSI). In addition to ISO 13485:2016 and MDSAP, the company quality system is established and maintained in alignment with global medical device regulations, including European Medical Device Regulation (EU) 2017/745, Australian Therapeutic Goods (Medical Devices) Regulations, U.S. FDA Quality Management System Regulation (QMSR) - 21 CFR Part 820. Circle continues to monitor regulatory developments and updates its quality system as required to ensure ongoing compliance with evolving global regulatory requirements.

Circle’s software development process incorporates several internationally recognized standards and guidance documents, including: BS EN (IEC) 62304:2006+A1:2015, BS EN (IEC) 62366-1:2015+A1:2020, and IEC 82304-1:2016. An intensive risk management process, based on BS EN (ISO) 14971:2019+A11:2021, is also implemented as part of the development process, to capture the potential harms, hazards, and hazardous situations, and to mitigate these identified risks.

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 QMS



Email: shirantha.samarappuli@circlecvi.com
Phone: +1 (587) 747-4692

BSI ISO 13485:2016 Certificate # FM 539204 (Effective: Aug 31st, 2024)
BSI ISO 13485:2016 Certificate # MDSAP 689664 (Effective: Aug 31st, 2024)