ISO 13485 Medical Devices Quality Management
From Delhi (India), we are a credible ISO 13485 Medical Devices Quality Management Service provider. The ISO 13485 Medical Devices Quality Management that we render is adequate and reliable. Our team of adroit professionals manages all the work to ensure the service is executed with 100% perfection and that too within the promised time period. The paper work is carried out with full attention and responsibility, so that the clients do not face any problem. Details : QSC has the capability and resources to support companies throughout the process of developing an effective Quality management for medical devices certification Program, performing independent audits of compliance-related processes and controls, and reporting on results. ISO 13485 is based on the ISO 9001:2008 process model approach and is a management systems standard specifically developed for the manufacture of medical devices. Its primary objective is to facilitate harmonized medical device regulatory requirements. The standard contains specific requirements for manufacture, installation and servicing and calls for: Implementation of a Quality Management System with several enhancements Risk Management approach to product development and product realization Validation of processes Compliance with statutory and regulatory requirements Effective product traceability and recall systems.
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