Circle Cardiovascular Imaging Inc. holds globally recognized ISO 13485:2016 and MDSAP certificates from the prestigious British Standards Institution (BSI). In addition to ISO 13485:2016 and MDSAP, the company quality system is established and maintained to comply with European Medical Device Directive 93/42/EEC, European Medical Device Regulation 2017/745, Australian Therapeutic Goods (Medical Devices) Regulations, US FDA Quality System Regulations 21 CFR Part 820, and other global medical device regulations.

Circle’s software development process incorporates several globally-recognized standards and guidances, 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
BSI ISO 13485:2016 Certificate # MDSAP 689664