Insights
A closer look at cardiovascular development.
Analysis of the evidence, software, quality and regulatory decisions that shape cardiovascular medical products.
ECG & evidence
Bench, analytical and clinical evidence in a cardiovascular program
October 20, 2026
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.
Read article : Bench, analytical and clinical evidence in a cardiovascular program
ECG & evidence
Device-agnostic ECG software: what the evidence needs to show
October 18, 2026
Why overall performance is only part of the conversation about supported devices and recording configurations.
Read article : Device-agnostic ECG software: what the evidence needs to show
FDA strategy
Plan FDA engagement before you commit to validation
October 18, 2026
Manufacturers should consider an FDA Pre-Submission early in product development, especially for their first submission. This allows for critical feedback to shape evidence strategy and schedule. Engaging with the FDA helps resolve uncertainties and informs validation plans, ultimately supporting a more effective submission process and reducing costly delays.
Read article : Plan FDA engagement before you commit to validation
QMS & software
A quality system that follows the development work
October 18, 2026
Requirements, risks, tests, and changes need a useful relationship in everyday engineering.
Read article : A quality system that follows the development work
ECG & evidence
Licensing an ECG algorithm: what remains with the manufacturer
October 18, 2026
The relationship between the licensed technology and the finished product deserves an explicit agreement.
Read article : Licensing an ECG algorithm: what remains with the manufacturer
EU MDR
Clinical evaluation: connect the claim to the evidence
October 18, 2026
A coherent device story starts before the clinical evaluation report is written.
Read article : Clinical evaluation: connect the claim to the evidence
Connected devices
When a customer integration becomes a product change
October 18, 2026
A new interface can introduce a different input, workflow, or use of the results.
Read article : When a customer integration becomes a product change
Regulatory intelligence
A regulatory update is only useful when you know what it changes
October 18, 2026
A practical way to connect new guidance to the product, evidence, and decisions already in progress.
Read article : A regulatory update is only useful when you know what it changesRegulatory intelligence
What a competitor’s clearance can—and cannot—tell you
October 18, 2026
Reading public regulatory records for useful context without treating them as a complete product dossier.
Read article : What a competitor’s clearance can—and cannot—tell you