A Success Story Unfolds
When the Co-founders of Neopenda, Sona Shah, CEO and Teresa Cauvel, CTO approached MAE Group they needed regulatory approval and quality system. Because their life saving product, NeoGuard, was ready for market, they came to MAE Group for their next steps.
To be clear, the NeoGuard addresses a health care crisis. In 2019, UNICEF reported that over 2.4 million neonates and infants died in their first month of life, the vast majority in the developing world. In fact, research shows that most of the deaths are preventable with vital signs monitoring.
Responding to the Call
Responding to the need, biomedical entrepreneurs Shah and Cauvel created a user-centered device. NeoGuard is a cost effective vital signs monitor designed to help provide high-quality care to neonates and infants in resource-strained health care facilities.
NeoGuard measures four primary vital signs and provides critical, timely date so that healthcare workers can respond rapidly and patients of all ages have the best chance to receive the care they need to survive and thrive. It saves lives. Globally.
MAE We Help?
The MAE Group Regulatory and Quality Team stepped in order to enable Neopenda to gain the necessary EU CE Mark approval and develop a quality system for NeoGuard. Not only did MAE Group develop the system, controls, and validations and the technical file dossier to approval, the team also aided Neopenda’s leadership transition and train their own Quality Engineer.
As Sona states, “Neopenda has enjoyed working with MAE Group’s thoughtful approach and expertise has enhanced our product development efforts and has given us confidence in our ability to deliver high quality products. The team’s responsiveness and ability to accommodate new challenges and questions is impressive.”
Neopenda’s success story is an excellent example of MAE Group commitment to service and bringing life-saving devices to global markets.
Now that’s a success story. Read more.