Lords Mark Industries Ltd. (LMIL), in partnership with Renalyx, has become the first Indian company to receive a CDSCO Class C license and international CE certification to manufacture AI-powered smart hemodialysis machines.
The granting of the licence to produce Class C World lst – AI Based Smart Hemodialysis Machines by the Central Drugs Standard Control Organisation (CDSCO) to Lords Mark Industries Ltd. (LMIL) has been a landmark in India med-tech industry through licence being the defining milestone in making India more self-reliant in regard to life-saving healthcare technology.
This is even more historic because LMIL-Renalyx has now been granted the internationally recognised CE marking, and it is one of the now six brands in the world to obtain the certification of a dialysis system. The CE marking is a certification that the product corresponds to the maximum health, safety and environmental protection requirements of the European Union, which allows entering the entire European Economic Area (EEA) on a legal basis.
One of the hardest regulatory feats in the med-tech regime of India is to get a licence to produce Class C World’s First AI-Based Smart Hemodialysis Machines. The Class C devices are under the high-risk and life-sustaining category hence any slight engineering or process variation can directly influence the survival of the patient. In order to acquire this licence, companies have to show complete compliance in almost 140+ quality, safety and risk-management parameters such as biocompatibility evidence, electromechanical safety proof, sterility evidence, traceability of each component, stringent documentation and multi-stage plant auditing. The number of manufacturers that do this category is very very small due to the fact that the standard of approval is similar to international standards. This certification is thus vital: the official permission which would enable LMIL to manufacture modern renal-care equipment within the country, decrease the reliance on imported devices at the national level, and provide the dialysis infrastructure in India with the globally-recognized, 100 percent compliant, life-saving technologies.
This has reached a crucial point of time in India. The USD 5 billion dialysis market of the country has a target population of 18-20 lakh CKD patients, 2.2-2.5 lakh new ESRD cases arise every year. However, India has less than 6,000 dialysis centres, and treatment demand is increasing with a CAGR of 10 12 percent, at the same time, the country is more than reliant on foreign equipment.
The innovation ecosystem of LMIL that lies at the center of this breakthrough drives the World’s First AI-Based Smart Hemodialysis Machines -created in collaboration with Renalyx. This next-generation system will combine the use of artificial intelligence to automate processes, offer predictive safety alerts, optimise treatment, and provide real-time analytics to minimise human error and increase clinical accuracy. The licence is a significant step towards the commercial scale adoption of this world-first technology.
Enhancing its innovation pipeline, LMIL-Renalyx has broadened a specific renal-care technologies, liver-care engineering, advanced sensing systems, and data-oriented renal informatics R&D ecosystem.
Remarking on this achievement, Sachidanand Upadhyay, the Managing Director, Lords Mark Industries Ltd., said: This licence is not a mere regulatory approval, it is a statement of the fact that India is capable of creating and dominating in the most advanced med-tech sectors in the world. Through our AI-powered smart Hemodialysis Machine and unremitting development team efforts, we will be able to revolutionize renal care in the world. Our vision is to develop smart, secure and affordable healthcare technologies in India, which can be used by the world.
The fact that LMIL-Renalyx is the first Indian company to produce an AI-Powered Smart Hemodialysis Machine and that it received the Indian manufacturing certificate and the international CE certification has preconditioned the new beginning of Indian medical technology which is characterized by innovation, quality, and international scope.
To get more information visit:- https://lordsmark.com/
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