Regulatory

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 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 ISO 14971:2007 and AAMI TIR 32:2004 Medical device software risk management in place to capture the potential risks and mitigate such risks as a part of the development process.

cmr⁴² has received the market clearance from Health Canada, US FDA, Australian TGA and European Union.

ct⁴² has received the market clearance from Health Canada & US FDA and Australian TGA and European Union approvals are pending.

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

BSI ISO 13485:2003 Certificate # FM 539204
Health Canada Device License for cmr⁴² # 78347
Health Canada Device License for ct⁴² # 87520
US FDA 510k for cmr⁴² # K082628
US FDA 510k for ct⁴² # K111373
BSI CE Certificate for cmr⁴² CE 539277
Australia TGA ARTG Certificate for cmr⁴² # 177785

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 Cardiovascular Quality System or the regulatory approval status for Circle product, 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

Australian Sponsor
K&D PTY Ltd
1/1 Main Street
Eastwood
South Australia 5063
Tel : 08 8271 2347