LN Lifecare operates its Medical Devices Manufacturing under the strict control of a Quality Management System as per the guidelines stated in the company Quality Policy & Quality Manual.  
  The purpose of the quality policy is to ensure compliance of quality systems and procedures so that the end product meets all the required specifications ensuring the identity, strength, safety & cleanliness of the products.  
  Quality Policy :  
  LN Lifecare will implement GMP as per SCHEDULE-M and quality management system as per   ISO 9001:2008, ISO 13485:2003, 21 CFR 820 and CE marking.  
  Quality is active and ongoing at LAKSHMINARAYANA LIFECARELN LifeCare follows a Quality Management System suitable for fulfillment of quality policy, achievement of quality objectives, conformance of statutory and regulatory requirements and achievement of planned business objectives.  
  LAKSHMINARAYANA LIFECARE Quality Management System is committed to meeting customer, statutory, and regulatory requirements and increasing customer satisfaction through continual improvement of its products, services, and it's Quality Management System.  The organization is committed to maintaining the effectiveness of the Quality Management System by means of internal audits, management reviews and corrective action and preventive action procedures for any Quality Management System non-conformances.  
  Our quality policy is “Pursuing Excellence in Healthcare”, The motto of the company is to offer state of the art and excellence in medical/surgical products to the Medical Professionals in the comprehensive healthcare sphere.  LN LifeCare is committed to develop innovative & high-tech products, to Manufacture High Quality Medical Devices, for international trade and channel development, distribution strategies, and marketing of medical/surgical high-tech products.”  
  This is achieved through the Quality principles and relevant operating Procedures to ensure that each product meets the customer’s requirements for safety, efficacy & quality.  These QUALITY principles are used in the planning, designing, construction, testing of Quality systems & Qualification of facilities. The Engineering/ Maintenance, Materials Management, Vendor development, Production, Quality Assurance & Quality Control departments are all required to comply with these Quality principles.  
  QUALITY is mandated and supported by top management and coordinated by Quality Assurance, which is responsibility of everyone in the plant. The effectiveness & applicability of Quality Assurance system is regularly monitored.  
  The products are analyzed at various stages during manufacturing, as per Quality Specifications.  The Quality Assurance Department checks the batch manufacturing records and the reports of analysis along with all data relevant to the quality, efficiency and safety of the product.  
  All the vendors for raw materials, components, sub-assemblies and assemblies have manufacturing licenses as per their local Food and Drug Administration (FDA).  LN approved vendors have WHO-GMP certifications, are ISO 13485 certified and have CE mark for their products.  
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