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Developed an FDA compliant automated external defibrillator for a Leading Medical Technology Company in the US

Industry

Healthcare

Services

Embedded Engineering , Product Innovation & Engineering

 

Overview

 

The client is one of the leading medical technology companies in the US delivering advanced and quality healthcare solutions and were looking to develop a multi-lingual automated voice intuitive defibrillator to treat heart conditions.

Challenges

 

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To develop a multi-lingual automated voice intuitive defibrillator

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Mitigating regulatory risks

 

 

Outcomes

 

  • The external defibrillator provided therapies for maintaining and restoring normal cardiac rhythms by passing or by delivering electrical shock therapy for cardioverting or defibrillating the heart
  • Delivered IEC 62304 and FDA (Medical Regulations) compliant solutions, mitigating regulatory risk associated with medical trial
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