MDR auditing process stage 1

MDR Auditing Process Stage 1

Auditing process under the MDR Conformity Assessment

Auditing process under the MDR Conformity Assessment

What manufacturers of medical devices should know about the planning of the stage 1 audit and the execution of MDR conformity assessments

The stage 1 audit forms part of the initial audit for all first-time applicants for MDR conformity assessment. The stage 1 audit can be conducted on- or off-site depending on the circumstances. In the stage 1 audit, the auditors check whether your company is ready to be audited.


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)



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