MDR Navigator-MDR and IVDR information

Example

A quality manager looking to confirm the specific requirements for risk management in the MDR can use the indexed search feature to find relevant sections and keywords instantly.

Scenario

A company developing a new medical device needs to ensure compliance with MDR. The quality manager uses the indexed search to quickly locate sections on risk management, ensuring all necessary protocols are in place before the product is launched.

Example

A regulatory affairs consultant needs to compare guidelines from different MDCG documents. They can access categorized documents to streamline the process of finding and cross-referencing the needed guidelines.

Scenario

When preparing a regulatory submission, the consultant uses the categorized documents feature to pull together various MDCG guidelines, ensuring the submission meets all applicable regulatory standards.

Example

A compliance officer reviewing the technical documentation of a medical device can use the cross-referencing capabilities to ensure all references within the documentation are correctly aligned with the latest MDR guidelines.

Scenario

During an internal audit, the compliance officer uses cross-referencing to verify that all cited standards and guidelines in the technical documentation are up-to-date and accurately applied, thereby ensuring a smoother audit process.