Is your laboratory software ready for future IVDR-related development?

Moving a laboratory instrument from research use into a clinical diagnostic environment involves more than regulatory documentation. Software architecture, traceability, data integrity, validation, cybersecurity, usability, and risk management all need to be considered.

Use our practical IVD Readiness Checklist for Connected Laboratory Software to assess your current software platform and identify areas that may require further attention before moving toward IVDR-related development.

With this checklist, you can:

✔ Assess your IVDR strategy and software classification
✔ Review software architecture, traceability, and data integrity
✔ Evaluate documentation and validation readiness
✔ Identify potential cybersecurity and integration gaps
✔ Review usability and software risk management
✔ Calculate your IVDR readiness score and identify potential next steps

Download the checklist to get a structured overview of your current readiness and identify potential gaps early.

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