Multi-channel ECG system modernization — Enterprise Case Study

MEDTECH · ECG · system architecture · risk analysis · Bluetooth

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Problem context

An existing multi-channel ECG device required modernization to improve manufacturability, update electronic components, and introduce Bluetooth 5.0 connectivity.

Constraints

  • Preservation of medical compliance
  • Risk mitigation during architecture changes
  • Compatibility with existing clinical workflows

Engineering decisions

Decision: Architecture-level redesign
Reason: Allows scalable upgrades and component replacement.
Trade-off: No immediate functional changes.
Decision: Early-stage risk analysis
Reason: Minimizes regulatory and technical risks.
Trade-off: Increased upfront design effort.

System overview

Updated system architecture for a multi-channel ECG device with modern electronics and wireless connectivity.

Outcome

Defined product architecture. Risk mitigation procedures. Foundation for further development.

Engagement delivered under NDA. Details anonymized.

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