Intended Users and Intended Patient Populations
Intended Users and Intended Patient Populations Intended Users of the medical device i...
Intended use and Indications of use of Medical Device
Intended Use and Indications of Use of Medical Device Intended use of a medical device define...
European Medical Device Nomenclature (EMDN CODE)
European Medical Device Nomenclature (EMDN) is the nomenclature that will be of use to the manufactu...
Product Conformity Verification
The Product Conformity Verification based on Annex XI of the MDR may be carried out for the medical ...
EU Type-Examination Certificate
EU TYPE-EXAMINATION CERTIFICATE According to the conformity assessment of the medical device through...
EU Technical Documentation Assessment Certificate
EU Technical Documentation Assessment Certificate The Notified Bodies follow chapter II of Annex IX ...
EU Quality Management System Certificate
The Notified Bodies follow the chapter I of Annex IX in MDR for the conformity assessment of the Qua...