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Internal Organizational Unit (IOU)
Adresa: Hvožďanská 2053/3, 148 00 Praha - Chodov
|Číslo||Název oddělení||Další specifikace|
|8801||director of IOU, secretary of IOU|
|8802||Unit for administration of orders and support|
|8810||Unit of project management|
|8811||Unit of project management|
|8830||Unit of external audits|
|8840||Unit of clinical evaluation|
|8804||Board for Final Review (KKP)|
|8803||Board for Authorization of Employees (KPP)|
|8805||Board for Decision about Certification (KRC)|
Medical Devices Certification Center (CMI Medical) is an internal organizational unit of CMI, which was entrusted with the preparation of the application for designation of CMI by a notified body in the field of conformity assessment of medical devices under Regulation (EU) No. 2017/745 (MDR).
The CMI application was submitted for all conformity assessment activities according to MDR – conformity assessment based on quality management system, assessment of technical documentation, conformity assessment based on type-examination, production quality assurance and product verification, for 23 basic and 17 horizontal (MD) codes. The competent authorities are currently in the process of reviewing the application and verifying that all the necessary conditions for the designation of CMI as a notified body for this area have been met.
In case of appointment of CMI as a notified body for the area of conformity assessment of medical devices according to the MDR, CMI Medical will ensure the provision of services of the notified body CMI in the field of certification of medical devices and supervisory activities. The services of the notified body will be carried out on the basis of a contract concluded with the customer - the manufacturer of medical devices.