Tag: Evidence planning
AI and sudden cardiac death: what should clinicians do with an ECG risk prediction?
A Nature study identifies an ECG signal associated with future sudden cardiac death. Its findings raise a practical development question: what action should a risk prediction support, and what evidence would justify it?
Reading a clearance summary without overreading the clearance
A clearance summary can inform an evidence budget or predicate shortlist. Its value depends on separating what the record establishes from what it leaves unanswered.
What determines the EU risk class of cardiovascular software?
EU software classification connects intended clinical use to the consequences of erroneous information. That reasoning also informs evidence, budget and conformity assessment.
Clinical evidence planning starts with the intended use
A well-run study can still leave a device claim unanswered. Map intended use to population, outcomes and evidence gaps before deciding which clinical work to commission.
What do the EU’s new notified-body timelines mean for your launch plan?
The EU’s new notified-body rules define assessment milestones, but launch timing still depends on evidence readiness, parallel work and interruptions. Learn what the clocks actually measure.
The code is ready. Is the SaMD change ready for release?
A passing build does not settle every release question. Connect clinical impact, evidence and submission decisions before committing to a SaMD change.
ECG-MR’s clearance shows the value and boundaries of a PCCP
A cleared ECG-MR change plan offers a practical example of connecting future model and compatibility updates to the evidence needed before release.
Bench, analytical and clinical evidence in a cardiovascular program
A cardiovascular device company faces complex decisions despite successful engineering results. Testing outcomes need clarity regarding their clinical relevance versus technical validation. Understanding distinctions between physical endurance, measurement accuracy, and clinical impact is crucial. Unresolved questions inform the necessary next steps for further investigation, highlighting the importance of targeted studies over generalized conclusions.