Quality

Pie Medical Imaging develops and sells its products in accordance with internationally accepted standards and is committed to maintain these standards. Pie Medical Imaging is also committed to consistently meet regulatory requirements in regions where the products are sold.

Regulatory information

European Economic Area
Products for the European Economic Area bear the CE0344 mark 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 made available.

United States
Pie Medical Imaging has 510(k) clearances for several products in compliance with the FDA Quality System Regulation 21CFR820. Please contact us for detailed information.

Other regions

For further product registrations, please contact PMI.

 

Quality Management System

Pie Medical Imaging’s quality management system is ISO 13485 and CAN/CSA ISO 13485 certified.

 

Anti-Corruption Compliance Program

Being part of the Esaote S.p.A Group, the Management System Guidelines Anti-Corruption policy aimed at preventing the commission of crimes of corruption are applicable.
Corporate bodies, employees and all the people cooperating in pursuing in any way the company’s aims must observe the values set out in the Code of Conduct.

» Code of Conduct