Combination Products
One product record for drug-device combination development
Why constituent-part teams need a shared evidence model - not parallel document libraries.
Combination products expose the cost of disconnected development. Drug, device, clinical, human-factors, quality, and manufacturing teams may each maintain accurate records while the integrated product story remains incomplete.
Map the integrated product
Begin with primary mode of action, constituent parts, lead and consulting authorities, product claims, and the interfaces where one constituent can affect another. Those interfaces are often where risk and evidence gaps accumulate.
Connect rather than duplicate
A shared product record should link CMC attributes, device design inputs, delivery performance, compatibility, stability, human factors, manufacturing controls, labeling, and post-market signals.
Use change as the test
If a formulation, supplier, software version, container, or assembly process changes, the system should identify every affected risk, test, document, jurisdiction, and filing assessment.
Further regulatory context
Read medical device regulatory definitions and authoritative references. Explore the workflows eeRegOS supports.
Editorial note: This content is educational and does not constitute legal or regulatory advice. Product-specific decisions should be reviewed by qualified professionals using current authoritative sources.