Pie Medical Imaging develops and sells its products in accordance with internationally accepted standards. We are committed to maintain them.
Medical Devices:
CE (European Market Regulations)
Medical Devices Directive (Council Directive 93/42/EEC of 14 June 1993 Concerning Medical Devices – amended by Directive 2007/47/EC). Products for the European market are notified to the DEKRA authorities and bear the CE 0344 mark.
On request, a Declaration of Conformity can be made available for each product.
FDA (USA Market Regulations):
FDA 510(k)
On request a copy of the clearance letter can be made available.
| CAAS IntraVascular | K123970 |
| 3mensio Workstation | K120367 |
| CAAS A-Valve | K113076 |
| CAAS QXA 3D | K100292 |
| CAAS MR Flow | K090155 |
| 3mensio Vision / Surgery | K072653 |
| CAAS QCA 3D | K063344 |
| CAAS MRV | K060941 |
| CAAS 5 (CAAS2000) | K052988 |
| CAAS MRV | K041682 |
| CAAS II RVA | K033920 |
| CAAS QIVA | K021495 |
| CAAS II QVA | K012475 |
| CAAS II LVA Biplane Option | K982203 |
| CAAS II | K945540 |
Quality Management System:
ISO 13485
Our quality management system is compliant with ISO 13485. The analytical software products realized with this process fulfill the regular requirements accepted worldwide.
CAN/CSA ISO 13485 (Canadian Market Regulations)
CAN/CSA ISO 13485 under CMDCAS. Pie Medical Imaging’s software development process is compliant with this standard. The analytical software products realized with this process fulfill the regular Canadian requirements for Medical Devices.
Software Development Process:
CMM
Pie Medical Imaging has been audited for compliance with the software development practices of CMM (Capability Maturity Model). The CMM framework provides software professionals with the ability to identify, adopt, and use sound management and technical practices for delivering software on time and within budget. Pie Medical Imaging’s compliance with CMM marks the effectiveness of efforts to serve our valued partners and customers as a reliable partner.
