About PMI
For more than 20 years, Pie Medical Imaging has been dedicated to efficient and effective analysis and visualization of medical images. In cooperation with clinical and research partners , we develop state-of-the-art solutions for our customers around the world.
Our vision
Imaging is a key part in medicine, from prevention to follow-up.
We make a difference by extracting relevant information out of medical information in an easy way.
Our mission
To provide cardiovascular image analysis solutions which assist the medical professional to improve patient treatment.
History
Our activities in quantitative analysis software, with Cardiovascular Angiographic Analysis Systems (Caas), started in 1984. In 1995, Pie Medical Imaging was founded to concentrate on the successful development and sales of quantitative analysis software.
In 1998, Pie Medical Imaging became part of the Esaote group. In 2
Quality
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 (Council Directive 93/42/EEC of 14 June 1993 Concerning Medical Devices – amended by Directive 2007/47/EC). On request, a Declaration of Conformity of a product can be provided.
In addition, Pie Medical Imaging’s quality management system is ISO13485:2016 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 ISO14971:2012 ‘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)
If you require further information on PMI’s quality management system or the regulatory approval status of PMI’s products, please contact PMI.
011, 3mensio Medical Imaging was acquired and Pie Medical Imaging took the responsibility to market the 3mensio product range next to its Caas products.