MDR auditing process pre-application

MDR Auditing Process Pre-Application

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.


medical devices

MDR Request for Service Registration

Be confident of medical device market approval

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MDR technical documentation assessment

MDR Technical Documentation Assessment Procedure

Assessment of the MDR Technical Documentation within the MDR conformity assessment procedure

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New Medical Device Regulation

The Medical Device Regulation

Understand the requirements of the MDR

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Mhs technical document

TÜV SÜD Technical Documentation

According to the Medical Device Regulation (EU) 2017/745 (MDR)



Next Steps

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