Auditing process under the MDR Conformity Assessment
Auditing process under the MDR Conformity Assessment
What manufacturers of medical devices should know about the pre-application auditing process for MDR conformity assessment
Once you have registered on our website, and resources are available, you will receive our MDR Conformity Assessment pre-application forms. We use the data collected in these pre-application forms to draw up your quotation. Acceptance of our quotation represents the start of the MDR Conformity Assessment application phase, which includes a more in-depth check of your MDR Conformity Assessment application documents.
Assessment of the MDR Technical Documentation within the MDR conformity assessment procedure
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According to the Medical Device Regulation (EU) 2017/745 (MDR)
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