Insights
A closer look at cardiovascular development.
Analysis of the evidence, software, quality and regulatory decisions that shape cardiovascular medical products.
Regulatory intelligence
Keeping the evidence strategy current as the field evolves
October 18, 2026
How new research and regulatory developments can inform an existing development program.
Read article : Keeping the evidence strategy current as the field evolves
FDA strategy
Predicate strategy begins with the product definition
October 18, 2026
Align intended use, technological characteristics, and the evidence questions before assembling a comparison.
Read article : Predicate strategy begins with the product definition
FDA strategy
A regulatory roadmap that supports development decisions
October 18, 2026
Make evidence needs, dependencies, and unresolved questions visible in milestone planning.
Read article : A regulatory roadmap that supports development decisionsECG & evidence
Signal quality belongs in the performance evaluation
October 18, 2026
Plan how recording conditions and unusable data will be handled before interpreting the results.
Read article : Signal quality belongs in the performance evaluation
QMS & software
Traceability should explain the product
October 18, 2026
Connect requirements, risk controls, design outputs, and tests so the relationships remain useful during change.
Read article : Traceability should explain the product
EU MDR
Build the remediation plan around the gaps that matter
October 18, 2026
Coordinate technical-documentation updates across intended purpose, risks, and evidence.
Read article : Build the remediation plan around the gaps that matter
EU MDR
PMCF planning starts with the questions that remain
October 18, 2026
Connect postmarket clinical work to the evidence needs of the specific cardiovascular device.
Read article : PMCF planning starts with the questions that remain