MiraCradle™ – Neonate Cooler, an affordable passive cooling device receives the prestigious CE and ISO 13485 certification
BANGALORE, INDIA June 15, 2016 – UL, a global safety science company, has recently awarded CE certification to MiraCradle™ – Neonate Cooler, an affordable cooling device developed by Pluss® in collaboration with CMC Vellore.
According to the World Health Organization, birth asphyxia or lack of sufficient oxygen supply to the brain around the time of birth, is one of the leading causes of neonatal death. Therapeutic Hypothermia, a form of treatment where the brain is moderately cooled, is presently considered an effective treatment for infants with birth asphyxia. MiraCradle™ – Neonate Cooler is a passive cooling device which uses advanced technology to maintain precise temperature control of 33-34°C for a period of 72 hours, in accordance to the treatment protocol of Therapeutic Hypothermia. Priced at 1/8th of the cost of currently available electronic devices for such treatment, MiraCradle™ also does not require much manual supervision, or constant electricity supply.
Compliance with safety and quality standards is crucial for risk assessment and management of medical devices, one of the most complex and deeply regulated markets in the world. As an independent third party certifying agency, UL provides a complete suite of services for medical device manufacturers for regulatory approvals, product testing, certification and usability testing.
Mr. Suresh Sugavanam, managing director and vice president, UL 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 certification helps build credibility of the product safety for intended use. This provides a level playing field and helps manufacturers to look at products in a holistic manner thereby enabling a platform for sustained growth of the industry.”
Mr. 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).”
UL experts worked closely with Pluss throughout the company’s regulatory journey to obtain CE and ISO certification.
Over 2 decades of being into extensive innovation and research, Pluss has been a pioneer in India on advanced Phase Change Materials Technology (PCM). It is proud to be the only Indian company engaged in research and development of PCMs for a wide range temperature requirement with several patents. For Pluss, customers come first and the focus is on creating value for them by designing innovative products and solutions in the field of Speciality Polymers and Phase Change Materials. Pluss PCMs used for providing solutions for energy efficient and reliable temperature controlled storage and transport applications are branded under the registered trademark of savE®. In Nov 2012, the company had an equity infusion from Tata Capital Innovations Fund which enabled Pluss develop new products and enter international markets. Pluss believes in consistent and pragmatic innovations. With its wide spread representative network in USA, Turkey, South East Asia, Russia, Ukraine and South Africa. Pluss® innovative products have seen tremendous growth in the recent years, making its presence felt across the globe.