ISO 13485 MEDICAL DEVICES MANAGEMENT

ISO 13485:2016 is a management system standard specifically developed for the manufacture of medical devices. The standard contains specific requirements for manufacture, installation and servicing of medical devices 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 13485:2016 Certificate helps the organization:

  • Quality Control
  • Risk Management
  • Legal Compliance
  • Traceability and Recall
  • Process Improvement
  • Product Improvement
  • Operational Efficiency