Insights
A closer look at cardiovascular development.
Analysis of the evidence, software, quality and regulatory decisions that shape cardiovascular medical products.
ECG & evidence
AI and sudden cardiac death: what should clinicians do with an ECG risk prediction?
October 25, 2026
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?
Read article : AI and sudden cardiac death: what should clinicians do with an ECG risk prediction?
Regulatory intelligence
Reading a clearance summary without overreading the clearance
October 24, 2026
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.
Read article : Reading a clearance summary without overreading the clearance
EU MDR
What determines the EU risk class of cardiovascular software?
October 24, 2026
EU software classification connects intended clinical use to the consequences of erroneous information. That reasoning also informs evidence, budget and conformity assessment.
Read article : What determines the EU risk class of cardiovascular software?
QMS & software
CAPA effectiveness: evidence that the problem stayed corrected
October 24, 2026
Implementing a correction is only part of the evidence. A useful CAPA effectiveness review connects the cause, the changed control and enough post-change observation to support closure.
Read article : CAPA effectiveness: evidence that the problem stayed corrected
ECG & evidence
Clinical evidence planning starts with the intended use
October 24, 2026
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.
Read article : Clinical evidence planning starts with the intended use
EU MDR
What do the EU’s new notified-body timelines mean for your launch plan?
October 24, 2026
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.
Read article : What do the EU’s new notified-body timelines mean for your launch plan?
QMS & software
Can your quality system reconstruct a SaMD release?
October 23, 2026
A quality system should make the evidence for a deployed SaMD version retrievable and understandable, across development tools and cloud operations.
Read article : Can your quality system reconstruct a SaMD release?
QMS & software
The code is ready. Is the SaMD change ready for release?
October 22, 2026
A passing build does not settle every release question. Connect clinical impact, evidence and submission decisions before committing to a SaMD change.
Read article : The code is ready. Is the SaMD change ready for release?
QMS & software
Design transfer for connected cardiovascular devices
October 20, 2026
A working development unit does not establish production readiness. Design transfer makes hardware, software configuration and acceptance decisions reproducible beyond the engineering team.
Read article : Design transfer for connected cardiovascular devices