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    Gap analysis tool for risk management compliance.

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IVDR Risk Management

Gap analysis tool for risk management compliance.

175 CHF plus VAT

  • Downloadable excel file that is clear, accessible and easy-to-use.
  • IVDR and ISO 14971:2019 compliance checklist of IVDR risk management requirements.
  • Gap analysis tool to show you how compliant your SOPs are against individual RM standards and IVDR requirements.
  • Identify an action plan using the checklist of tasks to complete to achieve compliance
  • Review and track SOP compliance with a % table summary measuring how complete the update is.
  • Maintain 100% compliance by using this tool after your SOP updates to ensure continued compliance.
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Description

This downloadable excel document is built for quality, regulatory and process owner teams to ensure that your standard operating procedures (SOP) comply with the risk management (RM) requirements set out in the in-vitro Diagnostics Medical Devices Regulation (EU) 2017/746 (IVDR) and defined by ISO 14971:2019. Designed as a unified, clear and easy-to-use document, this tool performs a gap analysis of the tasks you need to complete to comply with the IVDR and risk management requirements. It is also a review and progress report you can use after your updates to ensure that your SOP continues to maintain 100% compliance.

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