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.
To develop a multi-lingual automated voice intuitive defibrillator
Mitigating regulatory risks
- 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