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.
Extended transition period ends on May 26, 2024 for devices with valid MDD/AIMDD certification
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According to the Medical Device Regulation (EU) 2017/745 (MDR)
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