ISO 13485 Medical Devices Quality Management

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  • 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
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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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Company Details

There are many firms in the market who offer Certifications and Training services but fail to live up to the customer’s standards or provide a competitive rate for the services.

Realizing this gap in the market, a group of talented and knowledgeable professionals came together to form Quality Standard Certifications. Our motto is to provide value added services to our customers at a reasonable cost without compromising on quality.

Over the years our commitment to this motto has as earned us the reputation of being professional and dedicated to building relationships with its customer.
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" BEST SERVICE AT LESS ON DOORSTEP "

  • Business Type Service Provider
  • Total Number of Employees Below 20
  • Year of Establishment 2006
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  • Quality Standard Certifications
  • Pitampura, Delhi, Delhi India
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