ISO 13485 certification:

ISO 13485 is a Management Systems Standard specifically developed for the manufacture of Medical Devices. ISO 13485 is becoming widely accepted as the international standard to address medical device regulations around the world.
ISO 13485 has been harmonized against the three Directives (Medical Devices, In-vitro Diagnostic Devices and Active Implantable Devices) The main difference between ISO 9001 and ISO 13485 is that ISO 13485 is more focused towards ensuring medical device safety and efficacy rather than enhancing customer satisfaction and continual improvement. Once you implement processes and procedures that comply with the requirements listed in ISO 13485.

Benefits from ISO 13485 :

  • Increased efficiency
  • Cost savings
  • More effective risk management and quality assurance
  • An improved ability to respond to customer requirements are just a few of the potential results that certification to the standard can bring.
  • Certification to ISO 13485 satisfies a significant portion of the EU Directive requirements for marketing medical devices in Europe.

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