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.

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medical devices

MDR Request for Service Registration

Be confident of medical device market approval

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The New Medical Device Regulation (MDR)
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The New Medical Device Regulation

Extended transition period ends on May 26, 2024 for devices with valid MDD/AIMDD certification

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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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