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ISO 13485 Medical Devices Quality Management Systems

ISO 13485 is the medical industry’s optimal medical device standard, which ensures that all medical devices meet the proper regulatory compliance laws and customer needs. ISO 13485 certification is a valuable credential put in place to keep professionals and customers safe in clinics, hospitals and other medical settings.

ISO 13485is based on the ISO 9001 process model approach and is a management systems standard specifically developed for the manufacture of medical devices. Its primary objective is to facilitate harmonised medical device regulatory requirements. The standard contains specific requirements for manufacture, installation and servicing of medical devices

This standard allows companies to reduce safety and legal risks while creating more economical work environments. As an internationally recognised standard of quality and safety for medical device manufacturing, having ISO 13485 certification helps companies get recognised as more reputable, trustworthy providers

Benefits of ISO 13485:

  • Increase access to more markets worldwide
  • Increase the business competitive advantage
  • Meet relevant regulatory requirements and customer expectations
  • Demonstrate ability to produce safer and more effective medical devices
  • Improve operation efficiency through continual improvement processes