Regulatory Information

Pie Medical Imaging develops and sells its products in accordance with internationally accepted standards and is committed to consistently meet regulatory requirements applicable to medical device software in the various regional areas where its products are sold.

Pie Medical Imaging’s quality management system is established and maintained in compliance with the Medical Devices Directive (Regulation (EU) 2017/745)

In addition, Pie Medical Imaging’s quality management system is ISO13485:2016 and ISO13485:2016 MDSAP certified.

Pie Medical Imaging’s software development process complies with the requirements of the IEC 62304:200/A1:2015 ‘Medical Device Software – Software Life Cycle Processes’. For identification and mitigation of potential risks, a risk management process based on ISO14971:2019 ‘Medical Device Software Risk Management’ is implemented as part of the development process.

Pie Medical Imaging has received 510(k) clearance for the following products:

CAAS Workstation (K180019)
CAAS MR Solutions (K181825)
CAAS A-Valve (K143044)
3mensio Workstation - Vascular and Structural Heart (K153736)

Pie Medical Imaging B.V. Videos

State-of-the-art imaging for mitral valve interventions - PCR Valves e-Course 2020 - Video

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