When the Co-founders of Neopenda, Sona Shah, CEO and Teresa Cauvel, CTO approached MAE Group they needed regulatory approval and quality system. Their life saving product, NeoGuard, was developed, manufactured, and ready for market. They came to MAE Group for their next steps.
NeoGuard addressed 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. Most of the deaths are preventable with vital signs monitoring.
Biomedical entrepreneurs Shah and Cauvel responded with the innovative device, NeoGuard. 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.
In response to the COVID-19 pandemic, the Neopenda team began modifying the NeoGuard product and accelerated development so the device could be used for adults and pediatric patients affected by the virus.
As CEO, Sona Shah states, “COVID-19 has threatened the already fragile health infrastructures and disproportionately affects minorities; Neopenda is working towards providing equitable access to high-quality health care globally.”
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 Group Regulatory and Quality Team stepped in to gain 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 providing pre-market service to efficiently bring a truly life-saving product to market.
Now that’s a success story. Read more.