Medical Technology

MiraCradle – Neonate Cooler, receives the CE and ISO 13485 certification

MiraCradle – Neonate Cooler, an affordable cooling device developed by Pluss in collaboration with CMC Vellore, receives the prestigious CE certification and ISO 13485. UL, a premier global independent safety science company is the accredited body that certified MiraCradle.

MiraCradle – Neonate Cooler is an affordable passive cooling device which uses the advanced savE Phase Change Material (PCM) technology to cool newborns suffering from birth asphyxia. Birth asphyxia is the second largest cause of neonatal deaths in India and across the world. As per the WHO global health survey 2013, MiraCradleapprox. 650,000 newborn babies died because of birth asphyxia. MiraCradle has been developed by Pluss in collaboration with CMC Vellore. It is easy to use, safe, lightweight, portable and gives the precise temperature control of 33-34°C for a period of 72 hours with minimal manual supervision and no requirement of constant electricity supply. MiraCradle costs less than 1/8th of the present electronic devices available in the market.

Suresh Sugavanam, MD, UL India and South Asia said, “India as an emerging market continues to be relevant to the global medical technologies space, not just from a market point of view, but also as a global hub for innovation and manufacturing. These days there is a serious concern on the safety, quality and efficacy of the medical devices in India. A third party validation based on life cycle assessment approach builds credibility of the product. This provides a level playing field and helps manufacturers to look at products in a holistic manner”

Samit Jain, MD, Pluss said “Appropriate certifications are a must for any medical device manufacturer looking to make its presence felt globally. Pluss , with the vision of “Creating Impactful Innovations” is a new entrant to the medical device industry with its award winning MiraCradle being the first medical device Since the start, Pluss had decided to conform to the best quality and regulatory practices followed in the industry. Pluss, with global ambitions in mind, collaborated with UL in October 2014 to obtain the CE and ISO 13485 certification. After a rigorous process of audits, Pluss obtained the ISO 13485 certification in August 2015 and CE certification in May 2016. With the certifications in place, Pluss is now poised to expand the influence of MiraCradle across geographies (Middle East, Africa, South America and South East Asia)”

To ensure precise temperature control, MiraCradle- Neonate Cooler uses a cascaded system of PCMs. Cascaded system is a patented technology that employs use of two or more form stabilized PCM mattresses with melt/freeze at different temperatures. By engineering the melting points, thicknesses, conductivities and placement of the involved layers, a “quasi-automated” cooling system is created, which, while being completely passive, behaves like a servo-automated cooling device.

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