How the assessment works
Answer 25 questions. You will receive an overall score out of 100, separate scores for five readiness dimensions, and suggested next steps. Your answers are processed in your browser; this version does not submit them to a PHP handler or database.
Answer according to controls that are actually implemented and supported by evidence.
See which areas need further investigation, documentation or improvement.
Print or save your results as a PDF to discuss with your project team.
Your eDHR readiness results
Scores by readiness dimension
Recommended next steps
Complete the 25-question checklist
Select one answer per question. If a control is only planned, choose “No” or “Partially” as appropriate. Choose “Not sure” if you need to verify the evidence with the responsible team.
Scoring: Yes = 5 points; Partially = 2.5 points; No = 0 points; Not sure = 1 point. Each question has equal weight. The result is a directional planning aid, not a validated regulatory measurement.
What is an electronic Device History Record?
A Device History Record documents the production history of a medical device or applicable production lot, according to the manufacturer's processes and applicable requirements. An electronic Device History Record (eDHR) manages that information in an electronic workflow.
Depending on the product and process, an eDHR may connect work instructions, material and component information, operator actions, inspection and test results, process parameters, nonconformance handling, review and release decisions. The required contents and controls should be determined from applicable requirements, product risks and documented quality processes.
Moving from paper to electronic records is not only a software project. It can require process mapping, requirements definition, risk assessment, access control, data migration, system verification or validation, training and change management.
Explore related eDHR topics
Frequently asked questions
What is an eDHR readiness assessment?
It is a structured review of processes, systems, data controls, traceability, validation planning and training needed to support electronic Device History Records.
Does this checker certify regulatory compliance?
No. It is an educational self-assessment, not a compliance audit, legal opinion, certification or substitute for qualified review of applicable requirements.
Can we prepare for eDHR before buying software?
Yes. You can map existing processes, define record requirements, assess risks and establish responsibilities before selecting a platform. System-specific controls should then be evaluated once a solution is selected and configured.
What should we do after completing the assessment?
Review the lowest-scoring areas, verify answers with process owners, document gaps and risks, and develop a prioritized improvement plan.
Assessment limitations
This checker uses a simplified scoring model and relies on self-reported answers. It does not inspect systems, verify documents, assess product-specific risks or determine which laws and standards apply to an organization. The equal weighting of questions is a convenience for initial screening; it does not mean every control has equal regulatory or operational importance.