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...
CE Marking for Surgical Gowns and Drapes
Is CE Marking for Surgical Gowns and Drapes Mandatory for exporting to Europe? Is the Surgica...
EU Declaration of Conformity Medical Device
EU Declaration of Conformity Medical Device states that the requirements specified in the regulation...
MDR Conformity Assessment Routes
Chapter V section 2 of MDR Conformity Assessment Routes based on article 52. Conformity assessment r...