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ISO 13485


What is ISO 13485 Specifically developed for the manufacture of Medical Devices. :

Developed for the manufacture of Medical Devices.System Series, ISO 13485, 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 realisation Validation of processes Compliance with statutory and regulatory requirements Effective product traceability and recall systems .

ISO 13485 Model:

                    

Any organization can benefit from implementing ISO 13485as its requirements are underpinned by eight universal management principles.

  • Customer focused organization.
  • Leadership.
  • Involvement of people.
  • Ensuring process approach.
  • Systematic approach to management.
  • Factual approach to decision making.
  • Mutually beneficial supplier relations.
  • Continuous improvement.

ISO 13485

ISO 13485 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 realisation Validation of processes Compliance with statutory and regulatory requirements Effective product traceability and recall systems

Approach and Methodology

ISO 13485 Certification:

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