Developed an FDA Compliant Multi-lingual Automated Voice Intuitive Defibrillator to Treat Heart Conditions
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.
Download Case Study
Challenges
To develop a multi-lingual automated voice intuitive defibrillator
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